Appliance, Fixation, Spinal Interlaminal
FDA product code KWP · Class II (moderate risk) · 21 CFR 888.3050 · Orthopedic
430510(k) clearances
0PMA approvals
65recalls
Implantimplanted device
Manufacturers
- Medtronic Sofamor Danek 44
- Synthes (Usa) 17
- Danek Medical, Inc. 16
- Acromed Corp. 14
- Sofamor Danek USA,Inc. 13
- K2m, Inc. 12
- Depuy, Inc. 11
- Medtronic Sofamor Danek USA, Inc. 10
- Depuyacromed 10
- Sofamor Danek Mfg., Inc. 10
- Ortho Tec, LLC 9
- Blackstone Medical, Inc. 7
- Lanx, Inc. 7
- Globus Medical, Inc. 7
- Advanced Spine Fixation Systems, Inc. 7
- Interpore Cross Intl. 7
- Howmedica Osteonics Corp. 7
- Stryker Spine 7
- Zimmer, Inc. 7
- Warsaw Orthopedic, Inc. 6
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143278 | LnK Posterior Cervical Fixation SystemKWP · Traditional | L&K BIOMED Co., Ltd. | 07/29/2015SE |
| K150753 | OASYS SystemKWP · Traditional | Stryker Corporation | 06/09/2015SE |
| K150851 | Sure Lok Mini Posterior Cervical/Upper Thoracic SystemKWP · Special | Precision Spine, Inc. | 06/04/2015SE |
| K142867 | Reliance Posterior Cervical-Thoracic SystemKWP · Special | Reliance Medical Systems, LLC | 04/29/2015SE |
| K150254 | Streamline OCT Occipito-Cervico-Thoracic SystemKWP · Traditional | Pioneer Surgical Technology, Inc. (Dba Rti… | 04/28/2015SE |
| K142253 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/23/2015SE |
| K150229 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/07/2015SE |
| K143249 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/07/2015SE |
| K142741 | OASYS SystemKWP · Traditional | Stryker Corporation | 01/15/2015SE |
| K142558 | Caspian OCT/MESA Mini/DENALI Mini Spinal SystemKWP · Special | K2m | 12/22/2014SE |
| K140734 | Nextgen Altius Oct SystemKWP · Traditional | Ebi, LLC | 12/15/2014SE |
| K142460 | EXPEDIUM Spine System/Synapse SystemKWP · Special | Johnson and Johnson | 10/01/2014SE |
| K141897 | Synapse System, Synthes Oc Fusion SystemKWP · Traditional | Synthes USA Products, LLC | 09/25/2014SE |
| K141284 | Caspian Spinal SystemKWP · Special | K2m, Inc. | 07/23/2014SE |
| K133288 | Caspian Oct Spinal SystemKWP · Traditional | K2m, Inc. | 07/01/2014SE |
| K133556 | Virage Oct Spinal Fixation SystemKWP · Traditional | Zimmer Spine, Inc. | 06/02/2014SE |
| K140645 | Gibralt Rod-To-Rod Cross ConnectorsKWP · Special | Exactech Sarasota | 04/11/2014SE |
| K133374 | Streamline Oct Occipito-Cervico-Thoracic SystemKWP · Traditional | Pioneer Surgical Technology, Inc. (Rti Surgical, I | 03/19/2014SE |
| K133214 | Blackbird Spinal SystemKWP · Traditional | Choicespine, LP | 03/07/2014SE |
| K131833 | Centurion Poct SystemKWP · Traditional | Orthofix, Inc. | 01/30/2014SE |
| K132122 | Kestrel Posterior Cervical Spine SystemKWP · Traditional | Omni Surgical, LLC Dba Spine360 | 01/22/2014SE |
| K133698 | Synapse SystemKWP · Special | Synthes USA Products, LLC | 01/16/2014SE |
| K133094 | Certex Oct Spinal Implant SystemKWP · Traditional | X-Spine Systems, Inc. | 12/11/2013SE |
| K132504 | Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemKWP · Traditional | Corelink, LLC | 11/25/2013SE |
| K132900 | Marauder Cervical-Thoracic Spinal Fixation SystemKWP · Traditional | Intelligent Implant Systems, LLC | 10/25/2013SE |
| K131427 | LotusKWP · Traditional | Spinal Elements, Inc. | 10/24/2013SE |
| K132332 | Mountaineer Oct Spinal SystemKWP · Special | Medos International SARL | 08/22/2013SE |
| K131156 | Lanx Spinal Fixation SystemKWP · Special | Lanx, Inc. | 05/24/2013SE |
| K123906 | Vertex Reconstruction System, Vertext Select Reconstruction SystemKWP · Traditional | Medtronic Sofamor Danek USA, Inc. | 04/01/2013SE |
| K121979 | Pass Oct Spinal SystemKWP · Traditional | Medicrea International | 03/21/2013SE |
| K123783 | Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsKWP · Traditional | Globus Medical, Inc. | 03/14/2013SE |
| K123656 | Vertex Reconstruction System, Vertex Select Reconstruction SystemKWP · Traditional | Medtronic Sofamor Danek USA, Inc. | 02/25/2013SE |
| K121877 | Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…KWP · Traditional | Exactech, Inc. | 02/12/2013SE |
| K123232 | Spineology Spinous Process PlateKWP · Traditional | Spineology, Inc. | 02/07/2013SE |
| K123093 | Stabilink Mis Spinal Fixation SystemKWP · Traditional | Southern Spine, LLC | 12/20/2012SE |
| K123568 | Vertex Reconstruction SystemKWP · Special | Medtronic Sofamor Danek USA, Inc. | 12/18/2012SE |
| K122509 | Vertiflex Spinous Process Fixation PlateKWP · Traditional | Vertiflex, Inc. | 12/17/2012SE |
| K121725 | Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemKWP · Traditional | Pioneer Surgical Technology, Inc. | 11/07/2012SE |
| K122292 | Reliance Posterior Cervical- Thoracic SystemKWP · Traditional | Reliance Medical Systems, LLC | 10/24/2012SE |
| K120998 | Solstice Cross ConnectorKWP · Special | Life Spine | 10/01/2012SE |
| K122378 | Nextgen Altius Oct SystemKWP · Special | Biomet Spine (Aka Ebi, LLC) | 09/20/2012SE |
| K121136 | Renoir Posterior Cervial Fixation SystemKWP · Traditional | Accel Spine | 08/09/2012SE |
| K121808 | Casian, 3.5/4.5 ConnectorsKWP · Special | K2m, Inc. | 07/20/2012SE |
| K121115 | M.U.S.T Pedicle Screw SystemKWP · Traditional | Medacta International | 07/18/2012SE |
| K121191 | Vertex Rcconstruction SystemKWP · Traditional | Medtronic Sofamor Danek, Inc. | 06/29/2012SE |
| K113593 | Nextgen Altius Oct SystemKWP · Traditional | Biomet Spine (Aka Ebi, LLC) | 04/17/2012SE |
| K113324 | Rexious Hook Fixation SystemsKWP · Traditional | Dio Medical Co., Ltd. | 03/28/2012SE |
| K112757 | Pioneer Posterior Cervico Thoracic SystemKWP · Special | Pioneer Surgical Technology, Inc. | 03/12/2012SE |
| K113346 | Neon SystemKWP · Traditional | Ulrich GmbH & Co. KG | 02/28/2012SE |
| K112595 | Coflex-FKWP · Traditional | Paradigm Spine, LLC | 02/13/2012SE |
| K111719 | Oasys Spinal SystemKWP · Special | Stryker Spine | 01/19/2012SE |
| K113654 | CaspianKWP · Special | K2m, Inc. | 01/12/2012SE |
| K112592 | Axle PEEK Interspinous Fusion SystemKWP · Special | X-Spine Systems, Inc. | 12/05/2011SE |
| K112025 | Sure Lok Mini Posterior Cervical/Upper Thoracic SystemKWP · Traditional | Spinal USA | 09/15/2011SE |
| K103205 | Bridgepoint Spinous Process Camp- Posterior Fixation SystemKWP · Traditional | Alphatec Spine, Inc. | 06/02/2011SE |
| K111183 | Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods)KWP · Special | Orthofix, Inc. | 05/24/2011SE |
| K110963 | Ellipse Occipito-Cervico-Thoracic Spinal SystemKWP · Special | Globus Medical, Inc. | 05/05/2011SE |
| K103091 | Lanx Spinal Fixation SystemKWP · Special | Lanx, Inc. | 04/15/2011SE |
| K110353 | Mountaineer Oct Spinal SystemKWP · Special | Depuy Spine, Inc. | 04/07/2011SE |
| K110522 | Vertex Reconstruction System, Vertex Select Reconstruction SystemKWP · Special | Medtronic Sofamor Danek USA, Inc. | 04/01/2011SE |
| K110367 | Pioneer Spinal Process Fusion PlateKWP · Special | Pioneer Surgical Technology, Inc. | 03/23/2011SE |
| K102886 | CD Horizon Spinal SystemKWP · Traditional | Medtronic Sofamor Danek, Inc. | 01/26/2011SE |
| K102195 | Sp-Fix Spinous Process Fixation PlateKWP · Traditional | Globus Medical, Inc. | 01/19/2011SE |
| K103232 | Caspian Spinal SystemKWP · Special | K2m, Inc. | 01/13/2011SE |
| K101471 | Axle Interspinous Fusion SystemKWP · Traditional | X-Spine Systems, Inc. | 11/24/2010SE |
| K100888 | Modification to Lanx Posterior Cervicothoracic Spinal Fixation SystemKWP · Special | Lanx, Inc. | 11/15/2010SE |
| K101183 | Modification to: Oasys SystemKWP · Special | Stryker Spine | 11/09/2010SE |
| K101112 | Reliance Spinal Screw SystemKWP · Special | Reliance Medical Systems | 11/04/2010SE |
| K101525 | Pioneer Spinous Process Fusion PlateKWP · Traditional | Pioneer Surgical Technology | 10/22/2010SE |
| K093438 | Paradigm Interspinous Fusion PlateKWP · Traditional | Paradigm Spine, LLC | 10/06/2010SE |
| K101084 | Caspian Spinal SystemKWP · Traditional | K2m, Inc. | 10/04/2010SE |
| K102020 | Vega Span Spinous Process Plate SystemKWP · Traditional | Spinefrontier, Inc. | 09/01/2010SE |
| K100354 | Primal Ok Interspinous Fusion SystemKWP · Traditional | Osteomed LP | 08/17/2010SE |
| K093319 | Nuvasive Vuepoint Oct SystemKWP · Special | Nuvasive, Inc. | 06/23/2010SE |
| K100685 | Zodiac Polyaxial Spinal Fixation SystemKWP · Special | Alphatec Spine, Inc. | 06/18/2010SE |
| K100191 | Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)KWP · Special | Lanx, Inc. | 04/15/2010SE |
| K092825 | Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw WasherKWP · Special | Spinecraft, Inc. | 03/16/2010SE |
| K092295 | Pioneer Posterior Cervico-Thoracic SystemKWP · Traditional | Pioneer Surgical Technology | 02/19/2010SE |
| K093534 | Modification to Caspian Spinal SystemKWP · Special | K2m, Inc. | 12/16/2009SE |
| K092656 | Lanx Posterior Cervicothoracic Spinal Fixation SystemKWP · Traditional | Lanx, Inc. | 11/24/2009SE |
| K091359 | Gso PCT Spinal SystemKWP · Traditional | Gold Standard Orthopaedics, LLC | 09/02/2009SE |
| K090343 | Sentinel Spinal SystemKWP · Traditional | Life Spine | 08/11/2009SE |
| K091365 | Vertex Reconstruction System, Vertex Select Reconstruction SystemKWP · Traditional | Medtronic Soafamor Danek | 08/06/2009SE |
| K091689 | Synapse System 4.0MM, Oc Fusion System 4.0MMKWP · Special | Synthes (Usa) | 07/10/2009SE |
| K090565 | Ellipse Occipito-Cerico-Thoracic Spinal SystemKWP · Special | Globus Medical, Inc. | 06/30/2009SE |
| K090060 | Nexlink Oct System, Model 7000 SeriesKWP · Traditional | Abbott Spine, Inc. | 06/02/2009SE |
| K090549 | Synthes Synapse TransconnectorKWP · Special | Synthes Spine | 05/21/2009SE |
| K090714 | Vertex Reconstruction System, Vertex Select Reconstruction SystemKWP · Special | Medtronic Sofamor Danek | 04/17/2009SE |
| K090252 | Modification to: Lanx Spinal Fixation SystemKWP · Special | Lanx, Inc. | 03/04/2009SE |
| K082728 | Vertex Recontruction System, Vertex Select Reconstruction SystemKWP · Traditional | Medtronic Sofamor Danek USA, Inc. | 01/16/2009SE |
| K082769 | Mesa and Range Spinal SystemsKWP · Special | K2m, Inc. | 12/11/2008SE |
| K083071 | Vertex Reconstruction SystemKWP · Special | Medtronic Sofamor Danek | 11/14/2008SE |
| K081906 | Protex CT Cervicothoracic Spinal SystemKWP · Special | Globus Medical, Inc. | 11/14/2008SE |
| K081107 | Caspian Spinal System, Screws, Rods, Hooks, Rod ConnectorsKWP · Traditional | K2m, Inc. | 10/10/2008SE |
| K081297 | Vertex Reconstruction SystemKWP · Special | Medtronic Sofamor Danek | 06/11/2008SE |
| K080790 | Modification to Theken Atoll Cervico-Thoracic SystemKWP · Special | Theken Spine, LLC | 04/29/2008SE |
| K080805 | Modification to Vertex Reconstruction SystemKWP · Special | Medtronic Sofamor Danek | 04/18/2008SE |
| K072729 | SierraKWP · Special | Seaspine, Inc. | 04/17/2008SE |
| K080526 | Sierra SystemKWP · Special | Seaspine, Inc. | 04/16/2008SE |
| K073278 | Spinous Process Plate SystemKWP · Traditional | Nuvasive, Inc. | 03/28/2008SE |
| K080394 | Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) SystemKWP · Special | Blackstone Medical, Inc. | 03/13/2008SE |
| K073420 | Blackstone Ascent Multiaxial ScrewsKWP · Special | Blackstone Medical, Inc. | 02/14/2008SE |
| K073654 | Blackstone Ascent Poct System Parallel Rod ConnectorKWP · Special | Blackstone Medical, Inc. | 01/24/2008SE |
| K072866 | Issys LP Spinal Fixation SystemKWP · Traditional | Custom Spine, Inc. | 12/13/2007SE |
| K071942 | Modification to Vertex Reconstruction SystemKWP · Traditional | Medtronic Sofamor Danek | 12/11/2007SE |
| K072081 | Zodiac Dynamo Semi-Rigid Spinal SystemKWP · Traditional | Alphatec Spine, Inc. | 10/24/2007SE |
| K062447 | Traverse Oct Spinal Fixation SystemKWP · Traditional | Medtronic Sofamor Danek, Inc. | 10/15/2007SE |
| K072568 | Modification to Oasys SystemKWP · Special | Stryker Spine | 10/05/2007SE |
| K070742 | Modification to Vertex Reconstruction SystemKWP · Traditional | Medtronic Sofamor Danek | 09/14/2007SE |
| K071633 | Lanx Deformity SystemKWP · Special | Lanx, LLC | 08/15/2007SE |
| K070341 | LDR Spine Easyspine Posterior Osteosynthesis SystemKWP · Traditional | Ldr Spine USA | 08/08/2007SE |
| K071377 | Polaris Be RodsKWP · Traditional | Biomet Spine | 08/06/2007SE |
| K070966 | Gso GS1 Spinal SystemKWP · Traditional | Gold Standard Orthopaedics, LLC | 07/20/2007SE |
| K070638 | Theken Atoll Cervico-Thoracic SystemKWP · Traditional | Theken Spine, LLC | 05/30/2007SE |
| K061943 | Anatomica Posterior Cervical Fixation SystemKWP · Traditional | Anatomica AB | 05/25/2007SE |
| K070300 | Expedium SFX Cross Connector SystemKWP · Special | Depuy Spine, Inc. | 04/10/2007SE |
| K062181 | C-Jaws Cervical Compressive Mini FrameKWP · Traditional | Medicrea Technologies | 01/16/2007SE |
| K062785 | Ltd Polyaxial Fixation SystemKWP · Special | Us Spine | 12/26/2006SE |
| K062513 | Apex Spine SystemKWP · Traditional | Spinecraft, Inc. | 12/22/2006SE |
| K061591 | Modification to CD Horizon Spinal SystemKWP · Special | Medtronic Sofamor Danek, Inc. | 09/08/2006SE |
| K053418 | Synthes Oc Fusion SystemKWP · Traditional | Synthes Spine Co.Lp | 09/06/2006SE |
| K061579 | Modification to CD Horizon Spinal SystemKWP · Special | Medtronic Sofamor Danek | 08/11/2006SE |
| K052404 | Denali Deformity SystemKWP · Traditional | K2m, LLC | 05/23/2006SE |
| K060683 | Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemKWP · Traditional | Endius, Inc. | 04/18/2006SE |
| K060513 | Sintea Biotech PLS Multi-Axial Screws, Model PLS.XX.T5.XKWP · Special | Sintea Biotech, Inc. | 03/10/2006SE |
| K060081 | Basis Spinal SystemKWP · Traditional | Medtronic Sofamor Danek | 02/13/2006SE |
| K052201 | Solanas Posterior Stabilization SystemKWP · Traditional | Alphatec Spine, Inc. | 11/10/2005SE |
| K052734 | Modification to: Vertex Reconstruction SystemKWP · Special | Medtronic Sofamor Danek | 10/21/2005SE |
| K052131 | Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsKWP · Special | Depuy Spine, Inc. | 09/28/2005SE |
| K052402 | Vertex Reconstruction SystemKWP · Traditional | Medtronic Sofamor Danek | 09/23/2005SE |
| K052376 | Modification to: Vertex Reconstruction SystemKWP · Special | Medtronic Sofamor Danek | 09/23/2005SE |
| K052123 | Synthes Pangea SystemKWP · Special | Synthes (Usa) | 09/23/2005SE |
| K052247 | Nex-Link Spinal Fixation System Variable Crosslink, Model 721-XXKWP · Special | Abbott Spine, Inc. | 09/14/2005SE |
| K052181 | Modification to Xia Spinal SystemKWP · Special | Stryker Spine | 09/08/2005SE |
| K051716 | Vertebron PSS Pedicle Screw SystemKWP · Special | Vertebron, Inc. | 09/07/2005SE |
| K052180 | Modification to Vertex Reconstruction SystemKWP · Special | Medtronic Sofamor Danek | 08/23/2005SE |
| K051973 | Modification to: Xia Stainless Steel SystemKWP · Special | Stryker Spine | 08/18/2005SE |
| K052069 | Protex Stabilization System with Additional ComponentesKWP · Special | Globus Medical, Inc. | 08/17/2005SE |
| K051942 | Malibu Spinal SystemKWP · Traditional | Seaspine, Inc. | 07/27/2005SE |
| K050391 | Protex CT Cervicothoracic Spinal SystemKWP · Traditional | Globus Medical, Inc. | 07/21/2005SE |
| K050830 | Zodiac Spinal Fixation SystemKWP · Traditional | Alphatec/Nexmed | 06/22/2005SE |
| K050809 | CD Horizon Spinal SystemKWP · Traditional | Medtronic Sofamor Danek USA, Inc. | 06/14/2005SE |
| K050484 | Basis Spinal SystemKWP · Traditional | Medtronic Sofamor Danek, Inc. | 05/04/2005SE |
| K043053 | Modification to CD Horizon Spinal SystemKWP · Special | Medtronic Sofamor Danek | 04/11/2005SE |
| K050189 | Techtonix SystemKWP · Special | Stryker Spine | 02/16/2005SE |
| K050079 | CD Horizon Spinal SystemKWP · Special | Medtronic Sofamor Danek USA, Inc. | 02/10/2005SE |
| K043522 | Issys Pedicle Screw SystemKWP · Traditional | Custom Spine, Inc. | 01/14/2005SE |
| K043473 | Modification to Xia Spinal SystemKWP · Special | Stryker Spine | 01/12/2005SE |
| K042635 | Denali Spine SystemKWP · Traditional | K2m, LLC | 01/10/2005SE |
| K043020 | Glaxy 3.2 Spinal SystemKWP · Traditional | Medtronic Sofamor Danek | 01/07/2005SE |
| K043229 | Modification to Altius Oct SystemKWP · Special | Interpore Cross Intl. | 12/21/2004SE |
| K042789 | Vertex Reconstruction SystemKWP · Special | Medtronic Sofamor Danek | 12/21/2004SE |
| K043355 | Sintea Biotech Posterior Lumbar System with Polyaxial and Recovery Screws, Model…KWP · Special | Sintea Biotech, Inc. | 12/17/2004SE |
| K042673 | Zodiac Polyaxial Spinal Fixation SystemKWP · Special | Alphatec/Nexmed | 10/27/2004SE |
| K042524 | Modification to Vertex Reconstruction SystemKWP · Special | Medtronic Sofamor Danek | 10/08/2004SE |
| K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal SystemKWP · Special | Depuy Spine, Inc. | 10/07/2004SE |
| K042498 | Vertex Reconstruction SystemKWP · Special | Medtronic Sofamor Danek | 10/07/2004SE |
| K042143 | Excella-M Spinal SystemKWP · Traditional | Innovasis, Inc. | 10/07/2004SE |
| K042402 | Modification to Vertex Reconstruction SystemKWP · Special | Medtronic Sofamor Danek, Inc. | 10/01/2004SE |
| K041808 | Endius Title 2 Polyaxial Spinal SystemKWP · Special | Endius, Inc. | 10/01/2004SE |
| K041925 | ST360 Spinal Fixation SystemKWP · Special | Zimmer Spine, Inc. | 09/24/2004SE |
| K041592 | Coral Spinal SystemKWP · Traditional | Theken Surgical | 09/16/2004SE |
| K041862 | CD Horizon Spinal SystemKWP · Special | Medtronic Sofamor Danek | 09/15/2004SE |
| K041119 | Expedium Spine SystemKWP · Special | Depuy Spine, Inc. | 07/19/2004SE |
| K041449 | Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange Reduction SeatKWP · Special | Interpore Cross Intl. | 07/01/2004SE |
| K040096 | Spinal Concepts, Inc. Tandem Spinous Process Plate SystemKWP · Traditional | Spinal Concepts, Inc. | 07/01/2004SE |
| K041282 | Modification to TSRH Spinal SystemKWP · Special | Medtronic Sofamor Danek, Inc. | 06/10/2004SE |
| K033961 | Altius Oct SystemKWP · Special | Interpore Cross Intl. | 04/14/2004SE |
| K033090 | Icon Polyaxial Pedicle Screw SystemKWP · Traditional | Alphatec Mfg., Inc. | 03/26/2004SE |
| K033980 | Blackstone Ascent Poct System Hooks (System Modification)KWP · Special | Blackstone Medical, Inc. | 03/03/2004SE |
| K032094 | Passmed Spinal SystemKWP · Traditional | Medicrea | 11/14/2003SE |
| K031175 | Click'X Monoaxial Screws and HooksKWP · Traditional | Synthes (Usa) | 11/14/2003SE |
| K031471 | Oria Spinal Clip System, Lateral Intermediate Connector, Model AL01KWP · Traditional | Ortho Tec, LLC | 10/10/2003SE |
| K031772 | Ti Fenestrated PlateKWP · Abbreviated | Interpore Cross Intl. | 09/05/2003SE |
| K023884 | Modification Oria Spinal SystemKWP · Traditional | Ortho Tec, LLC | 08/20/2003SE |
| K031893 | Xia Spinal System and Xia Stainless Steel SystemKWP · Special | Howmedica Osteonics Corp. | 07/17/2003SE |
| K031595 | U & I America Spinal Hook SystemKWP · Traditional | U&I Corp., America | 06/24/2003SE |
| K030875 | Modification to Colorado 2 Spinal SystemKWP · Special | Medtronic Sofamor Danek, Inc. | 06/24/2003SE |
| K031452 | Oria Spinal Clip System, Sacral Connector, Models CA03 and AO03KWP · Special | Ortho Tec, LLC | 06/18/2003SE |
| K031533 | Vantage Anterior Fixation SystemKWP · Special | Medtronic Sofamor Danek, Inc. | 06/13/2003SE |
| K030197 | Blackstone Posterior Cervical SystemKWP · Traditional | Blackstone Medical, Inc. | 06/12/2003SE |
| K030816 | MSD Cable Reduction SystemKWP · Traditional | Medtronic Sofamor Danek | 06/06/2003SE |
| K031090 | Modification to Xia Stainless Steel SystemKWP · Special | Howmedica Osteonics Corp. | 04/24/2003SE |
| K030253 | Oria Spinal Clip System, Lengthened Lateral Connector, Model AL06KWP · Special | Ortho Tec, LLC | 02/21/2003SE |
| K030252 | Oria Spinal Clip System Extended Omniaxial Connectors (CO05 & CO07)KWP · Special | Ortho Tec, LLC | 02/21/2003SE |
| K030241 | Modification to Blackstone Spinal Fixation SystemKWP · Special | Blackstone Medical, Inc. | 02/21/2003SE |
| K023804 | Moss Miami Spinal System Pin NutKWP · Special | Depuyacromed | 01/23/2003SE |
| K023797 | Laurain Dewald Anterior Fixation SystemKWP · Special | Medtronic Sofamor Danek | 12/13/2002SE |
| K023415 | Modification to Dynalok Classic Spinal SystemKWP · Special | Medtronic Sofamor Danek | 12/13/2002SE |
| K014296 | CD Horizon Spinal SystemKWP · Traditional | Medtronic Sofamor Danek | 12/10/2002SE |
| K022048 | Interpore Cross International (Ici) Occipito-Cervico-Thoracic (Oct) Rod and Plate SystemKWP · Traditional | Interpore Cross Intl. | 12/04/2002SE |
| K023675 | Synthes Cervifix/ AxonKWP · Special | Synthes (Usa) | 11/26/2002SE |
| K023555 | Modification to Vertex Reconstruction SystemKWP · Special | Medtronic Sofamor Danek, Inc. | 11/22/2002SE |
| K021679 | Oria Spinal Clip SystemKWP · Traditional | Ortho Tec, LLC | 11/19/2002SE |
| K023498 | Modification to Blackstone Spinal Fixation SystemKWP · Special | Blackstone Medical, Inc. | 11/13/2002SE |
| K022374 | Cadence Spinal Fixation SystemKWP · Special | Sulzer Spine-Tech | 09/24/2002SE |
| K022191 | Modification to Tenor Spinal SystemKWP · Special | Medtronic Sofamor Danek, Inc. | 08/28/2002SE |
| K022623 | 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)KWP · Special | Depuyacromed | 08/27/2002SE |
| K021507 | Plus Pivot Link Universal SystemKWP · Traditional | Spine Vision, Inc. | 08/01/2002SE |
| K021061 | Modification to CD Horizon Spinal SystemKWP · Special | Medtronic Sofamor Danek | 07/25/2002SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1413-2023 Class II | INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm…Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of… | Medtronic Sofamor Danek USA Inc | 02/16/2023Open, Classified |
| Z-1412-2023 Class II | INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 26mm…Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of… | Medtronic Sofamor Danek USA Inc | 02/16/2023Open, Classified |
| Z-1411-2023 Class II | INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW…Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of… | Medtronic Sofamor Danek USA Inc | 02/16/2023Open, Classified |
| Z-1410-2023 Class II | INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 32mm…Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of… | Medtronic Sofamor Danek USA Inc | 02/16/2023Open, Classified |
| Z-1409-2023 Class II | INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm…Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of… | Medtronic Sofamor Danek USA Inc | 02/16/2023Open, Classified |
| Z-1307-2022 Class II | Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and…Some of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace… | K2M, Inc. | 06/13/2022Open, Classified |
| Z-0706-2022 Class II | Everest MI XT Outer Dilator, Catalog Number 5101-90168Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting… | K2M, Inc | 01/13/2022Open, Classified |
| Z-0705-2022 Class II | Everest MI XT Inner Dilator, Catalog Number 5101-90167Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting… | K2M, Inc | 01/13/2022Open, Classified |
| Z-1941-2020 Class II | VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628Nonconforming product; length of the product measured shorter than the labeled length. | Medtronic Sofamor Danek USA Inc | 03/26/2020Terminated |
| Z-1473-2020 Class II | Iliac Screws, multiple sizes, Article Nos. B36020500 B36020570 B36020580 B36020590…An internal component was assembled in the incorrect orientation, which may lead to the tulip head… | Medicrea International | 01/28/2020Terminated |
| Z-1472-2020 Class II | Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540…An internal component was assembled in the incorrect orientation, which may lead to the tulip head… | Medicrea International | 01/28/2020Terminated |
| Z-1350-2020 Class II | Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for…Due to a production error, the weld seam of the "Locking screw for crosslink, screw-to-screw" cannot… | ulrich medical USA Inc | 12/31/2019Terminated |
| Z-0828-2020 Class II | Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded | Medicrea International | 09/16/2019Open, Classified |
| Z-0827-2020 Class II | Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded | Medicrea International | 09/16/2019Open, Classified |
| Z-1735-2019 Class II | Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System…Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking. | Zimmer Biomet, Inc. | 11/14/2018Terminated |
| Z-0867-2019 Class II | Vitality Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation…The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality… | Zimmer Biomet Spine Inc. | 07/30/2018Terminated |
| Z-1023-2017 Class II | Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type…Damaged packaging, lack of sterility assurance | Medacta Usa Inc | 12/07/2016Terminated |
| Z-0290-2017 Class II | RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x…RTI Surgical Inc. (RTI) is conducting a voluntary recall on two specific lots of the Streamline OCT Straight… | RTI Surgical, Inc. (dba Pioneer Surgical… | 09/16/2016Terminated |
| Z-1829-2016 Class II | Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal…Potential for a product defect where the cannula may be obstructed. This obstruction could prevent a driver… | RTI Surgical, Inc. (dba Pioneer Surgical… | 04/22/2016Terminated |
| Z-1826-2016 Class II | Various trauma and sports medicine instruments and implants. Spinal interlaminal…Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | Biomet, Inc. | 04/01/2016Terminated |
| Z-1393-2016 Class II | RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw…Multiple lots of the 26-FNLDRIVER, may have reduced mechanical strength, resulting in driver tip fracturing… | RTI Surgical, Inc. (dba Pioneer Surgical… | 03/18/2016Terminated |
| Z-1019-2016 Class II | Virage OCT Spinal Fixation System. Intended to promote fusion of the…Zimmer Biomet Spine is initiating a Medical Device Correction regarding the Virage OCT Spinal Fixation… | Zimmer Spine, Inc. | 02/03/2016Terminated |
| Z-0625-2016 Class II | Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system…Zimmer Biomet is initiating a recall of the Virage Occipital Eyelet, as it was found through product testing… | Zimmer Biomet, Inc. | 11/17/2015Terminated |
| Z-2759-2015 Class II | Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers…Biomet has initiated a recall on Biomet Spine Lineum OCC Starter Flexible and its inner shaft… | Biomet Spine, LLC | 07/22/2015Terminated |
| Z-0855-2014 Class II | Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product…Orthofix received 6 complaints which resulted in a reportable events due to extended surgical times greater… | Orthofix, Inc. | 11/26/2013Terminated |
| Z-0574-2015 Class II | Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only…Possibility of the weld to the quick-connect breaking when force is applied to the handle for pedicle screw… | Zimmer, Inc. | 08/26/2013Terminated |
| Z-1976-2013 Class I | Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini.…Stryker has received reports from customers indicating post-operative fracture of the pin that connects the… | Stryker Spine | 05/30/2013Terminated |
| Z-0896-2013 Class II | Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod…There is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connector Assembly… | Orthofix, Inc | 02/01/2013Terminated |
| Z-2573-2014 Class II | STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE…Some set screw thread profiles were found not to be within specifications. | Pioneer Surgical Technology, Inc. | 09/10/2012Terminated |
| Z-0412-2013 Class II | Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide…Inspan Compressors may break at weld causing a loss of compression | SpineFrontier, Inc. | 08/28/2012Terminated |
| Z-3044-2011 | TSRH(R) Spinal System SCREW, REF 837-645, Size: 6.5mm x 45mm, Mat'l: TITANIUM ALLOY, Rx…Screws are 5 mm longer than the size etched on the screw. | Medtronic Sofamor Danek USA Inc | 07/12/2011Terminated |
| Z-0967-2013 Class II | ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY…The rods were incorrectly laser etched as ILLICO Straight CP Tl Rods, 110mm, when they were in fact… | Alphatec Spine, Inc. | 07/06/2011Terminated |
| Z-2878-2011 | ATLANTIS (R) Self-Tapping Variable Angle Screw, Rx only, Medtronic Sofamor Danek USA…Screws are longer then size etched on the screw. | Medtronic Sofamor Danek USA Inc | 06/28/2011Terminated |
| Z-2877-2011 | VERTEX (R), REF 69004440, cortical screw, Rx only, Medtronic Sofamor Danek USA, 1800…Screws are longer then size etched on the screw. | Medtronic Sofamor Danek USA Inc | 06/28/2011Terminated |
| Z-2875-2011 | CD HORIZON (R) LEGACY (TM) MAS, REF 75445540, pedicle screw, Rx only, Medtronic Sofamor…Screws are longer then size etched on the screw. | Medtronic Sofamor Danek USA Inc | 06/28/2011Terminated |
| Z-2874-2011 | CD HORIZON (R) LEGACY (TM) FAS, REF 7542535, pedicle screw, Rx only, Medtronic Sofamor…Screws are longer then size etched on the screw. | Medtronic Sofamor Danek USA Inc | 06/28/2011Terminated |
| Z-0269-2013 Class II | TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product…The recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw Assembly was… | Alphatec Spine, Inc. | 12/09/2010Terminated |
| Z-0932-2012 | Solanas Posterior Stabilization System Part Number: 63920. Solanas Posterior…These lots were not manufactured correctly in that the instrument does not have the durability required to… | Alphatec Spine, Inc. | 11/01/2010Terminated |
| Z-0525-2010 | Abbott Spine Thoracolumbar Common, SpdLnk 5.5 Trans Cntr Med 43-51 mm, non-sterile…The titanium stock used to manufacturer the product is reported to exhibit areas of alloy segregation, which… | Zimmer Inc. | 09/21/2009Terminated |
| Z-0503-2010 | Alphatec Spine Solanas Titanium Pedicle Screw Part Number 63035-14Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body… | Alphatec Spine, Inc. | 08/05/2009Terminated |
| Z-0502-2010 | Alphatec Spine Solanas Titanium Pedicle Screw, Part Number 63035-12Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body… | Alphatec Spine, Inc. | 08/05/2009Terminated |
| Z-2312-2009 | Multi-Axial Screw (TI); 8.00MM (D) x 70MM(L) W/Collar; Biomet Spine, Parsippany, NJ…Some devices could have been made with raw material lots that may have inclusions, and could result in… | Ebi, L.P. | 04/02/2009Terminated |
| Z-1927-2009 | Malibu Polyaxial Reduction Screw, 6.5 x 50mm Part Number 13-6550 Malibu Spinal System…SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat… | SeaSpine, Inc | 03/04/2009Terminated |
| Z-1926-2009 | Malibu Polyaxial Reduction Screw, 6.5 x 45mm Part Number 13-6545 Malibu Spinal System…SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat… | SeaSpine, Inc | 03/04/2009Terminated |
| Z-1925-2009 | Malibu Polyaxial Reduction Screw, 6.5 x 40mm Part Number 13-6540 Malibu Spinal System…SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat… | SeaSpine, Inc | 03/04/2009Terminated |
| Z-1924-2009 | Malibu Polyaxial Screw, 7.5 x 70mm Part Number 12-7570 Malibu Spinal System when used as…SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat… | SeaSpine, Inc | 03/04/2009Terminated |
| Z-1923-2009 | Malibu Polyaxial Screw, 7.5 x 35mm Part Number 12-7535 Malibu Spinal System when used as…SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat… | SeaSpine, Inc | 03/04/2009Terminated |
| Z-1922-2009 | Malibu Polyaxial Screw, 6.5 x 50mm Part Number 12-6550 Malibu Spinal System when used as…SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat… | SeaSpine, Inc | 03/04/2009Terminated |
| Z-1921-2009 | Malibu Polyaxial Screw, 6.5 x 45mm Part Number 12-6545 Malibu Spinal System when used as…SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat… | SeaSpine, Inc | 03/04/2009Terminated |
| Z-1920-2009 | Malibu Polyaxial Screw, 6.5 x 40mm Part Number 12-6540 Malibu Spinal System when used as…SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat… | SeaSpine, Inc | 03/04/2009Terminated |