Orthosis, Spondylolisthesis Spinal Fixation
FDA product code MNH · Class II (moderate risk) · 21 CFR 888.3070 · Orthopedic
309510(k) clearances
0PMA approvals
14recalls
Implantimplanted device
Manufacturers
- Medtronic Sofamor Danek 17
- Acromed Corp. 14
- Depuyacromed 13
- Howmedica Osteonics Corp. 9
- Sofamor Danek USA,Inc. 9
- Advanced Spine Fixation Systems, Inc. 8
- Synthes (Usa) 6
- Solco Biomedical Co., Ltd. 6
- Ebi, L.P. 6
- U&I Corporation 6
- Ortho Tec, LLC 6
- Osteonics Corp. 5
- Spineart 5
- Scien'Tx USA, Inc. 4
- United States Surgical, A Division of Tyco Healthc 4
- Nuvasive, Inc. 4
- Stryker Spine 4
- Cross Medical Products, Inc. 3
- J.B.S., S.A. 3
- Blackstone Medical, Inc. 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162066 | Reliance Spinal Screw SystemMNH · Traditional | Reliance Medical Systems, LLC | 12/02/2016SE |
| K162801 | CastleLoc Spinal Fixation SystemMNH · Special | L&K BIOMED Co., Ltd. | 11/03/2016SE |
| K162143 | FixxSure® X-LinkMNH · Traditional | Innovasis, Inc. | 09/23/2016SE |
| K161151 | Spinal fixation systemMNH · Traditional | Canwell Medical Co., Ltd. | 09/21/2016SE |
| K162189 | ANAX 5.5 Spinal SystemMNH · Special | U&I Corporation | 08/30/2016SE |
| K151362 | HC Spinal SystemMNH · Traditional | Hung Chun Bio-S Co., Ltd. | 05/05/2016SE |
| K153404 | Zavation Spinal SystemMNH · Traditional | Zavation, LLC | 04/21/2016SE |
| K160020 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemMNH · Special | Captiva Spine | 03/02/2016SE |
| K143013 | Spinal Inner Fixation SystemMNH · Traditional | Changzhou Dingjian Medical Appliance Co., Ltd. | 12/11/2015SE |
| K151695 | Romeo posterior osteosynthesis systemMNH · Traditional | Spineart | 09/10/2015SE |
| K151116 | CapLOX II/TowerLOX Pedicle Screw SystemMNH · Special | Captiva Spine | 06/26/2015SE |
| K150283 | Republic Spine Dark Star Spinal SystemMNH · Traditional | Republic Spine, LLC | 04/29/2015SE |
| K142798 | PASS LP Spinal SystemMNH · Traditional | Medicrea International SA | 03/25/2015SE |
| K143417 | ANAX 5.5 Spinal SystemMNH · Traditional | U&I Corporation | 02/25/2015SE |
| K143377 | PedFuse Pedicle Screw SystemMNH · Special | Spinefrontier, Inc. | 02/12/2015SE |
| K142957 | Ideal pedicle screw spinal systemMNH · Traditional | Jiangsu Ideal Medical Science & Technology Co.… | 01/30/2015SE |
| K142655 | CB PROT II Posterior Spinal SystemMNH · Traditional | Chin Bone Technique Corp | 01/26/2015SE |
| K140359 | Maximis Spinal Fixation SystemMNH · Traditional | Valorem Surgical | 01/07/2015SE |
| K142290 | KangLi pedical screw spinal systemMNH · Traditional | Suzhou Kangli Orthopaedics Instrument Co., Ltd. | 11/24/2014SE |
| K134011 | General Spinal SystemMNH · Traditional | Changzhou Dean Medical Instrument Co, Ltd. | 09/03/2014SE |
| K133575 | Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…MNH · Traditional | Spinevision S.A. | 06/30/2014SE |
| K141376 | Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…MNH · Special | Nexxt Spine, LLC | 06/26/2014SE |
| K140053 | Kangli Pedicle Screw Spinal SystemMNH · Traditional | Suzhou Kangli Orthopaedics Instrument Co., Ltd. | 06/26/2014SE |
| K140678 | Cosmolock Pedicle Screw SystemMNH · Traditional | Kalitec Direct, LLC | 06/19/2014SE |
| K140787 | PLS (Posterior Lumbar System)MNH · Special | Sintea Plustek, LLC | 05/30/2014SE |
| K140948 | Romeo Posterior Osteosynthesis SystemMNH · Special | Spineart | 05/20/2014SE |
| K133153 | Spinefrontier Pedfuse Pedicle Screw SystemMNH · Special | Spinefrontier, Inc. | 05/14/2014SE |
| K133690 | True Spinal Fussion SystemMNH · Traditional | Innovative Surgical Designs | 05/07/2014SE |
| K133287 | Presson Spinal Fixation SystemMNH · Traditional | Nexus Spine, LLC | 02/25/2014SE |
| K132403 | Annextm Adjacent Level SystemMNH · Traditional | Spine Wave, Inc. | 01/10/2014SE |
| K132218 | Perfix Iliac Screw SystemMNH · Traditional | U&I Corporation | 12/17/2013SE |
| K132101 | Anax 5.5 Spinal SystemMNH · Traditional | U&I Corporation | 11/25/2013SE |
| K131810 | Osseus Black Diamond Pedicle Screw SystemMNH · Traditional | Osseus Fusion Systems, LLC | 08/08/2013SE |
| K131538 | Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemMNH · Special | Captiva Spine | 08/08/2013SE |
| K130267 | Romeo Posterior Osteosynthesis SystemMNH · Traditional | Spineart | 05/31/2013SE |
| K122994 | Intramedullary Nail SystemMNH · Traditional | Weigao Orthopaedic Device Co., Ltd. | 04/12/2013SE |
| K123487 | Gso GS1 Cannulated Screw SystemMNH · Traditional | Gold Standard Orthopaedics, LLC | 03/11/2013SE |
| K123164 | Spinefrontier Pedfuse Pedicle Screw SystemMNH · Traditional | Spinefrontier, Inc. | 02/15/2013SE |
| K123476 | Mega 5.5 Spine SystemMNH · Traditional | Lsk Biopartners, Inc. | 01/08/2013SE |
| K122592 | Instinct Java SystemMNH · Traditional | Zimmer Spine | 01/04/2013SE |
| K122814 | Galleon Pedicle Screw SystemMNH · Traditional | Everest Spine, LLC | 12/03/2012SE |
| K120832 | Fortex Pedicle Screw SystemMNH · Special | X-Spine Systems, Inc. | 10/23/2012SE |
| K121016 | Range Spinal System (Mesa and Denali)MNH · Special | K2m, Inc. | 06/27/2012SE |
| K120760 | LDR Spine Spinetune TL Spinal SystemMNH · Special | Ldr Spine USA, Inc. | 06/27/2012SE |
| K111940 | S 100 Pedicle Screw SystemMNH · Special | Renovis Surgical Technologies, LLC | 05/15/2012SE |
| K120491 | DSS Stabilization System-RigidMNH · Traditional | Paradigm Spine, LLC | 05/09/2012SESU |
| K120353 | Synster Pedicle Screw System Synster Plus Pedicle Screw SystemMNH · Traditional | Bm Korea Co., Ltd. | 05/09/2012SE |
| K103573 | ARTS2 Spinal Fixation SystemMNH · Traditional | Advanced Medical Technologies | 12/28/2011SE |
| K110633 | Lancer Pedicle Screw SystemMNH · Special | Spinal Solutions, LLC | 12/15/2011SE |
| K111995 | Xingtm Spine SystemMNH · Traditional | Implanova Co., Ltd. | 12/12/2011SE |
| K111690 | Devine Spinal SystemMNH · Traditional | Changzhou Orthmed Medical Instrument Co., Ltd. | 11/22/2011SE |
| K110497 | Pass LP Spinal SystemMNH · Special | Medicrea International | 09/26/2011SE |
| K111370 | Odalys Pedicle Screw SystemMNH · Traditional | Kalitec Direct, LLC | 09/21/2011SE |
| K111362 | Rexious Spinal Fixation SystemMNH · Special | Dio Medical Co., Ltd. | 07/21/2011SE |
| K102458 | 4CIS Solar Spine System and 4CIS Apollon Spine SystemMNH · Special | Solco Biomedical Co., Ltd. | 06/13/2011SE |
| K110321 | Tiger Spine SystemMNH · Traditional | Corelink, LLC | 05/25/2011SE |
| K101374 | Aaxter A3 Posterior Spinal SystemMNH · Traditional | Aaxter Co., Ltd. | 03/16/2011SE |
| K102574 | Palla M Spinal SystemMNH · Traditional | Korea Bone Bank Co., Ltd. | 03/07/2011SE |
| K102636 | Zenith Pedicle SystemMNH · Traditional | Apollo Spine, Inc. | 03/03/2011SE |
| K101818 | 4CIS Vane Spine SystemMNH · Traditional | Solco Biomedical Co., Ltd. | 02/11/2011SE |
| K103085 | Venus Basic Spinal Fixation SystemMNH · Special | L&K BIOMED Co., Ltd. | 02/09/2011SE |
| K102853 | Flamenco Spinal Fixation SystemMNH · Traditional | Ulrich GmbH & Co. KG | 01/25/2011SE |
| K102870 | Exactech Proliant Polyaxial Pedicle Screw SystemMNH · Traditional | Exactech, Inc. | 01/21/2011SE |
| K101446 | Emerald Spinal SystemMNH · Traditional | Mazor Surgical Technologies , Ltd. | 01/20/2011SE |
| K101278 | Inertia Pedicle Screw SystemMNH · Special | Nexxt Spine, LLC | 12/20/2010SE |
| K102488 | Apex Spine System W/ Cocr RodsMNH · Special | Spinecraft, LLC | 12/10/2010SE |
| K093771 | Quantum/Streamline TL Mis Spinal SystemMNH · Traditional | Pioneer Surgical Technology | 08/10/2010SE |
| K101678 | Romeo Posterior Osteosynthesis SystemMNH · Special | Spineart | 07/28/2010SE |
| K100706 | Venus Basic Spinal Fixation SystemMNH · Traditional | L&K BIOMED Co., Ltd. | 07/22/2010SE |
| K100956 | Spondy Spinal Fixation SystemMNH · Traditional | Allure Spine LLC | 07/09/2010SE |
| K100373 | Tyche Pedicle Screw SystemMNH · Traditional | Kyung Won Medical Co., Ltd. | 06/30/2010SE |
| K100605 | Mis SystemMNH · Traditional | Spine Wave, Inc. | 06/04/2010SE |
| K093670 | Modification to: Oasys SystemMNH · Special | Stryker Spine | 03/18/2010SE |
| K100122 | Modification to Capsure PS SystemMNH · Special | Spine Wave, Inc. | 02/12/2010SE |
| K091725 | Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020 (Total: 549)MNH · Traditional | U&I Corp. | 11/09/2009SE |
| K092011 | Norm Spinal SystemMNH · Traditional | Norm Tibbi Urunler Ithalat Ihracat Sanayi VE Ticar | 10/28/2009SE |
| K083077 | Ulc Spinal Pedicle Screw SystemMNH · Traditional | Otis Biotech Co., Ltd. | 10/26/2009SE |
| K083567 | Gii Spinal Fixation System, Gii-Ti-Poly Axial ScrewMNH · Special | Co-Ligne AG | 09/14/2009SE |
| K090224 | Fortex Pedicle Screw SystemMNH · Special | X-Spine Systems, Inc. | 07/30/2009SE |
| K090477 | Alpine Pedicle Screw SystemMNH · Traditional | Sanacor | 07/27/2009SE |
| K091110 | Spinal Edge Titan Pedicle Screw SystemMNH · Traditional | Spinal Edge, LLC | 07/24/2009SE |
| K090424 | DVX Spine SystemMNH · Traditional | Bk Meditech, Co., Ltd. | 05/14/2009SE |
| K090228 | Roc Lumbar Plating SystemMNH · Traditional | Alphatec Spine, Inc. | 04/29/2009SE |
| K083581 | Lanx Spinal Fixation SystemMNH · Special | Lanx, Inc. | 04/07/2009SE |
| K080611 | Mesa Spinal SystemMNH · Special | K2m, Inc. | 03/04/2009SE |
| K081153 | Novel Spinal SystemMNH · Traditional | Medyssey Co, Ltd. | 01/30/2009SE |
| K083826 | Laguna Polyaxial Pedicle Screw SystemMNH · Special | Allez Spine, LLC | 01/22/2009SE |
| K081165 | Ellipse Lumbar Posterior Osteosynthesis SystemMNH · Traditional | Spineart | 12/17/2008SE |
| K082509 | Eos Spinal SystemMNH · Traditional | Korea Bone Bank Co., Ltd. | 12/15/2008SE |
| K082577 | Pass LP Spinal SystemMNH · Special | Medicrea Technologies | 10/03/2008SE |
| K081883 | Modification to Preference Pedicle Screw SystemMNH · Traditional | Us Spine | 09/24/2008SE |
| K082453 | 4CIS Solar and Apollon Spine SystemsMNH · Special | Solco Biomedical Co., Ltd. | 09/23/2008SE |
| K081331 | Fixxsure Cross LinkMNH · Traditional | Spineworks, LLC | 07/23/2008SE |
| K081631 | Sintea Biotech PLS Multi-Axial ScrewsMNH · Special | Sintea Biotech, Inc. | 07/18/2008SE |
| K081041 | GPS, G Surgical Pedicle SystemMNH · Traditional | G Surgical Co., Ltd. | 06/27/2008SE |
| K080828 | Mountaineer Oct Spinal SystemMNH · Special | Depuy Spine, Inc. | 06/27/2008SE |
| K081381 | Range Spinal System, Large Denali ScrewsMNH · Special | K2m, Inc. | 06/13/2008SE |
| K081296 | Preference Pedicle Screw SystemMNH · Special | Us Spine | 06/06/2008SE |
| K080876 | DVX Spine SystemMNH · Traditional | Bk Meditech, Co., Ltd. | 06/04/2008SE |
| K073531 | Accin Pedicle Screw SystemMNH · Traditional | Accelerated Innovation, LLC | 02/04/2008SE |
| K071890 | Zodiac 4.0 Polyaxial Spinal Fixation SystemMNH · Traditional | Alphatec Spine, Inc. | 11/09/2007SE |
| K070530 | Modification to Passmed Spinal SystemMNH · Special | Medicrea Technologies | 10/18/2007SE |
| K072282 | Capless Li Pedicle Screw SystemMNH · Special | X-Spine Systems, Inc. | 09/14/2007SE |
| K070933 | Lowtop Pedicle Screw SystemMNH · Traditional | Sanacor | 06/13/2007SE |
| K062670 | Vertiflex Spinal Screw SystemMNH · Traditional | Vertiflex (Tm), Incorporated | 01/12/2007SE |
| K062174 | Modification to Expedium Spine SystemMNH · Special | Depuy Spine, Inc. | 11/02/2006SE |
| K061524 | Iss Integrated Spine SystemMNH · Traditional | Ortho Development Corp. | 09/26/2006SE |
| K061813 | Mantis Spinal SystemMNH · Traditional | Stryker Spine | 09/19/2006SE |
| K061577 | Ovaltwist Pedicle Screw SystemMNH · Traditional | Signus Medizintechnik GmbH | 09/14/2006SE |
| K062196 | SFX Snap-Fit Cross ConnectorMNH · Traditional | Depuy Spine, Inc. | 09/11/2006SE |
| K061364 | Pilot Posterior Lumbar Plating SystemMNH · Traditional | Life Spine | 09/05/2006SE |
| K062317 | Modification to Nuvasive Spherx II SystemMNH · Special | Nuvasive, Inc. | 09/01/2006SE |
| K061162 | Bar Pedicle Screw Spinal Fixation System, Model 2020MNH · Traditional | Applied Spine Technologies, Inc. | 07/26/2006SE |
| K061915 | CD Horizon Spinal SystemMNH · Special | Medtronic Sofamor Danek | 07/25/2006SE |
| K061441 | Ebi 5.5 Helical Flange Spinal SystemMNH · Traditional | Ebi, L.P. | 07/25/2006SE |
| K061778 | Nuvasive Spherx II SystemMNH · Special | Nuvasive, Inc. | 07/18/2006SE |
| K053623 | Nfix Fusion SystemMNH · Traditional | N-Spine, Inc. | 07/12/2006SE |
| K061321 | Zodiac Adjustable Bridges, Models 11-20XX,11-25XX,11-30XX,11-35XXMNH · Special | Alphatec Spine, Inc. | 07/07/2006SE |
| K060702 | 4CIS Vane Spine SystemMNH · Traditional | Solco Biomedical Co., Ltd. | 06/22/2006SE |
| K060118 | SSP Pedicle Screw SystemMNH · Traditional | Specialty Spine Products, LLC | 06/08/2006SE |
| K060225 | Nuvasive Spherx SystemMNH · Special | Nuvasive, Inc. | 04/12/2006SE |
| K053573 | GSS Pedicle Screw SystemMNH · Traditional | GS Medical Co., Ltd. | 03/08/2006SE |
| K053070 | Contour II Spinal SystemMNH · Traditional | Altiva Corp. | 02/13/2006SE |
| K051089 | Gii Spinal Fixation SystemMNH · Traditional | Co-Ligne AG | 10/26/2005SE |
| K051959 | NV Cormed Solas Spinal SystemMNH · Traditional | Nv Cormed | 10/12/2005SE |
| K051044 | Arctec Semirigid Plating SystemMNH · Traditional | Altiva Corp. | 10/07/2005SE |
| K051697 | Selective-Axis Posterior Noncervical Plating SystemMNH · Traditional | Medical Device Advisory Development Group | 09/21/2005SE |
| K050461 | Xia 4.5 Spinal SystemMNH · Traditional | Stryker Spine | 07/27/2005SE |
| K051216 | Hydralok SystemMNH · Traditional | Altiva Corp. | 07/19/2005SE |
| K051286 | Zodiac Spinal Fixation SystemMNH · Special | Alphatec/Nexmed | 06/17/2005SE |
| K050471 | 4CIS Solar Spine System and 4CIS Apollon Spine SystemMNH · Traditional | Solco Biomedical Co., Ltd. | 05/12/2005SE |
| K043578 | The 4CIS Spinal System and 4CIS Low Back SystemMNH · Traditional | Solco Biomedical Co., Ltd. | 03/07/2005SE |
| K043180 | Stryker Spine Trio PSMNH · Traditional | Stryker Spine | 03/02/2005SE |
| K050078 | Roc Lumbar Plating SystemMNH · Traditional | Alphatec/Nexmed | 02/18/2005SE |
| K042928 | Modification to Global Spinal Fixation SystemMNH · Special | U&I Corp. | 02/17/2005SE |
| K043152 | Vertebron PSS Pedicle Screw SystemMNH · Special | Vertebron, Inc. | 02/01/2005SE |
| K043343 | Modification to: CD Horizon Spinal SystemMNH · Special | Medtronic Sofamor Danek | 12/28/2004SE |
| K043001 | MX Polyaxial Pedicle ScrewMNH · Special | Scient'X | 12/01/2004SE |
| K042640 | Uni-Thread Spinal SystemMNH · Traditional | Spine Vision, Inc. | 11/23/2004SE |
| K042964 | MX Monoaxial Pedicle ScrewMNH · Special | Scient'X | 11/22/2004SE |
| K040747 | Aladyn Rigid Spine PlateMNH · Special | Scient'X | 06/17/2004SE |
| K033512 | Procyon Spinal SystemMNH · Traditional | Nas Medical Technologies, Inc. | 06/03/2004SE |
| K040442 | Protex Stabilization SystemMNH · Traditional | Globus Medical, Inc. | 05/20/2004SE |
| K034056 | Modification to CD Horizon Spinal SystemMNH · Special | Medtronic Sofamor Danek | 04/21/2004SE |
| K033546 | Nuvasive Spinal SystemMNH · Traditional | Nuvasive, Inc. | 04/12/2004SE |
| K040072 | Modification to CD Horizon Spinal SystemMNH · Special | Medtronic Sofamor Danek, Inc. | 02/12/2004SE |
| K032604 | Gii Spinal Fixation SystemMNH · Traditional | Co-Ligne AG | 01/20/2004SE |
| K033322 | Modification to CD Horizon Spinal SystemMNH · Special | Medtronic Sofamor Danek | 12/15/2003SE |
| K032855 | Stryker Spine Maps SystemMNH · Traditional | Howmedica Osteonics | 12/10/2003SE |
| K031265 | Shiraz-Java Spinal Fixation SystemMNH · Traditional | Spine Next SA | 10/09/2003SE |
| K031585 | U&I, Optima, Spinal SystemMNH · Special | U&I Corp., America | 06/27/2003SE |
| K031423 | Ebi P148 Spinal Fixation SystemMNH · Traditional | Ebi, L.P. | 06/27/2003SE |
| K023378 | Oria ClarisMNH · Traditional | Ortho Tec, LLC | 06/27/2003SE |
| K030581 | Blackstone Spinal Fixation System Lateral Offset (System Modification)MNH · Special | Blackstone Medical, Inc. | 06/26/2003SE |
| K031290 | Modification to Easys Transverse ConnectionMNH · Special | Scient'X USA, Inc. | 05/13/2003SE |
| K030383 | Modification to Moss Miami Spinal System Polyaxial ScrewsMNH · Special | Depuyacromed | 02/26/2003SE |
| K023994 | Oria Spinal Clip System, Types BD and BJMNH · Special | Ortho Tec, LLC | 02/05/2003SE |
| K024348 | Monarch Spine SystemMNH · Special | Depuyacromed | 01/28/2003SE |
| K020085 | Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.XMNH · Traditional | Sintea Biotech, Inc. | 12/10/2002SE |
| K023438 | Modification to Monarch Spine SystemMNH · Special | Depuyacromed | 11/13/2002SE |
| K023204 | Modification to Ebi OMEGA21 Spinal Fixation SystemMNH · Special | Ebi, L.P. | 10/18/2002SE |
| K021623 | Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsMNH · Special | Iame, Inc. | 09/10/2002SE |
| K021881 | Endius Title Spinal Fixation SystemMNH · Traditional | Endius, Inc. | 07/29/2002SE |
| K020356 | Alpha Mirage Top Tightening Spinal SystemMNH · Traditional | Alphatec Mfg., Inc. | 07/23/2002SE |
| K020247 | Colorado 2 Spinal SystemMNH · Traditional | Medtronic Sofamor Danek, Inc. | 07/22/2002SE |
| K021335 | Monarch Spine SystemMNH · Traditional | Depuyacromed | 07/11/2002SE |
| K021880 | Crossover Cross Connector (Moss Miami Spine System)MNH · Special | Depuyacromed | 06/26/2002SE |
| K021879 | Crossover Cross Connector (Isola Spinal System)MNH · Special | Depuyacromed | 06/26/2002SE |
| K013962 | Equation Fixation SystemMNH · Traditional | Medtronic Sofamor Danek, Inc. | 06/20/2002SE |
| K020699 | TSRH Spinal SystemMNH · Traditional | Medtronic Sofamor Danek, Inc. | 05/28/2002SE |
| K021148 | Monarch Spine System Commercially Pure Titanium Spinal RodMNH · Special | Depuyacromed | 05/08/2002SE |
| K020681 | Ebi OMEGA21 Spinal Fixation SystemMNH · Special | Ebi, L.P. | 04/03/2002SE |
| K020674 | Blackstone Spinal Fixation System 4.5MM Multi-Axial ScrewMNH · Traditional | Blackstone Medical, Inc. | 04/03/2002SE |
| K014302 | Universal Multiaxis (Unimax) Pedicle Screw SystemMNH · Traditional | Pisharodi Surgicals, Inc. | 03/29/2002SE |
| K020196 | Modification to Silhouette Spinal Fixation SystemMNH · Special | Sulzer Spine-Tech | 02/15/2002SE |
| K020293 | Osteonics Spinal SystemMNH · Special | Howmedica Osteonics Corp. | 02/14/2002SE |
| K013887 | Bacfix Spinal Fixation SystemMNH · Traditional | Spinal Concepts, Inc. | 02/12/2002SE |
| K020245 | Modification to Isobar Spinal SystemMNH · Special | Scien'Tx USA, Inc. | 02/01/2002SE |
| K014229 | Modification to Opus Spinal SystemMNH · Special | Howmedica Osteonics Corp. | 01/25/2002SE |
| K014137 | Modification to Ebi Omega 21 SystemMNH · Special | Ebi, L.P. | 01/16/2002SE |
| K014076 | Modification to TSRH Spinal SystemMNH · Special | Medtronic Sofamor Danek, Inc. | 12/27/2001SE |
| K013688 | Modification to Xia Spinal SystemMNH · Special | Howmedica Osteonics Corp. | 12/05/2001SE |
| K013444 | Isobar Spinal SystemMNH · Special | Scien'Tx USA, Inc. | 11/16/2001SE |
| K013296 | Moss Miami Spinal SystemsMNH · Special | Depuyacromed | 10/09/2001SE |
| K013295 | Timx Spinal SystemsMNH · Special | Depuyacromed | 10/09/2001SE |
| K013294 | Monarch Spinal SystemsMNH · Special | Depuyacromed | 10/09/2001SE |
| K012971 | Isola Spinal SystemsMNH · Special | Depuyacromed | 10/05/2001SE |
| K012273 | Spiral Radius 90-D SST SystemMNH · Special | United States Surgical, A Division of Tyco Healthc | 08/15/2001SE |
| K012027 | Modification to Xia Spine SystemMNH · Special | Howmedica Osteonics | 07/20/2001SE |
| K003733 | SCS Closed ScrewMNH · Traditional | Ortho Tec, LLC | 05/29/2001SE |
| K011182 | Modified Moss Miami 4.35MM Diameter Polyaxial ScrewsMNH · Special | Depuyacromed | 05/16/2001SE |
| K010369 | Claris Plate SystemMNH · Traditional | Ortho Tec, LLC | 05/08/2001SE |
| K010845 | Modification to Osteonics Spinal SystemMNH · Special | Howmedica Osteonics Corp. | 04/18/2001SE |
| K010742 | Moss Miami 5.5MM Titanium Pin NutMNH · Special | Depuyacromed | 04/12/2001SE |
| K010720 | TSRH Spinal SystemMNH · Special | Medtronic Sofamor Danek, Inc. | 04/11/2001SE |
| K003463 | Socon Spinal SystemMNH · Special | Aesculap, Inc. | 04/11/2001SE |
| K010776 | Trinity Polyaxial Screw, Mehdian Spinal Rod (6MM), Model 159.XXX Series Catalogue NumbersMNH · Special | Corin USA | 04/06/2001SE |
| K010535 | Trifix Spinal Fixation SystemMNH · Special | Endius, Inc. | 03/19/2001SE |
| K010249 | CD Horizon Spinal SystemMNH · Special | Medtronic Sofamor Danek, Inc. | 02/23/2001SE |
| K003764 | Modification to Ebi Spinelink SystemMNH · Special | Ebi, L.P. | 01/02/2001SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1884-2017 Class II | 5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is…The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cobalt Chromium. | Xtant Medical Inc | 04/12/2017Terminated |
| Z-0883-2017 Class II | Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm…The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is… | Amendia, Inc | 11/22/2016Terminated |
| Z-1823-2015 Class II | Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc.…The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length. | X Spine Systems Inc | 04/07/2015Terminated |
| Z-1512-2015 Class II | Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal…One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm… | X Spine Systems Inc | 03/11/2015Terminated |
| Z-0938-2013 Class II | Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part…Lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly etched as… | Synthes USA HQ, Inc. | 01/11/2013Terminated |
| Z-0168-2013 Class II | ILLlCO MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System…The firm initiated the recall because the stainless steel guide-wire of the Illico MIS Fixation System did… | Alphatec Spine, Inc. | 09/25/2012Terminated |
| Z-1886-2009 | Stryker Trio Connector Hex Socket for Torque Wrench 3.5MM Not Sterile: Manufactured by:…The Trio 3.5MM Hex socket has been reported to break under high stresses. | Stryker Spine | 07/01/2009Terminated |
| Z-1612-2009 | Stryker Mantis Rod Inserter Inner Shaft; Non Sterile; Manufactured by Stryker Spine SAS…The Mantis Rod Inserter Shaft was found to have deformation of the stainless stell split sphere when… | Stryker Spine | 04/30/2009Terminated |
| Z-1611-2009 | Stryker Mantis Rod Inserter; Non Sterile, Manufactured by Stryker Spine SAS, Cestas…The Mantis Rod Inserter Shaft was found to have deformation of the stainless stell split sphere when… | Stryker Spine | 04/30/2009Terminated |
| Z-2308-2009 | Fixed Closed Screw (Ti); 5.0MM (D) x 25MM (L); Made in USA, 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-2307-2009 | Fixed Open Screw (TI); 7.0MM (D) x 30MM (L); Made In USA, 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-2306-2009 | Fixed Closed Screw, 6.5mm (D) x 40mm (L), Made in USA; Biomet Spine, Parsippany, NJ The…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-1694-2009 | Capless Li Pedicle Screw System, Diameters - 4.75mm, 5.5mm, 6.5mm, 7.5mm, 8.25mm…A defect cause was discovered following a customer complaint pertaining to a post operative dissociation of… | X Spine Systems Inc | 03/24/2009Terminated |
| Z-2059-2015 Class II | Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107.…Incorrect thread form on the screw. | Exactech, Inc. | 03/06/2009Terminated |