Spinal Vertebral Body Replacement Device
FDA product code MQP · Class II (moderate risk) · 21 CFR 888.3060 · Orthopedic
279510(k) clearances
0PMA approvals
43recalls
Implantimplanted device
Manufacturers
- Medtronic Sofamor Danek 30
- Globus Medical, Inc. 11
- Spine Wave, Inc. 10
- Interpore Cross Intl. 10
- Depuyacromed 8
- K2m, Inc. 8
- Stryker Spine 8
- Signus Medizintechnik GmbH 8
- Ldr Spine USA 8
- Implex Corp. 8
- Ebi, L.P. 6
- Blackstone Medical, Inc. 6
- Nuvasive, Inc. 6
- Synthes Spine 6
- Medtronic Sofamor Danek USA, Inc. 6
- Nu Vasive, Incorporated 5
- Spinal Concepts, Inc. 5
- Synthes (Usa) 4
- Osteotech, Inc. 4
- Quantum Orthopedics, Inc. 4
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261810 | Vertiwedge® Intraosseous SystemMQP · Special | Foundation Surgical Group | 07/31/2026SE |
| K261031 | Poseidon STMQP · Traditional | Signus Medinzintechnik GmbH | 07/10/2026SE |
| K253158 | VyBrate VBR SystemMQP · Traditional | Vy Spine, LLC | 01/07/2026SE |
| K241468 | Vertiwedge® Intraosseous SystemMQP · Traditional | Foundation Surgical Group, Inc. | 11/07/2024SE |
| K232790 | KONG®-TL VBR System and KONG® C VBR SystemMQP · Traditional | Icotec AG | 04/04/2024SE |
| K233359 | DOMINION Expandable Corpectomy SystemMQP · Traditional | Astura Medical | 03/08/2024SE |
| K231134 | VerteLoc Spinal SystemMQP · Traditional | Signature Orthopaedics Pty, Ltd. | 02/13/2024SE |
| K232173 | Ascend VBR System, Ascend NanoTec VBR SystemMQP · Traditional | Alphatec Spine, Inc. | 10/06/2023SE |
| K211892 | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)MQP · Traditional | Arftx Medical, LLC | 10/06/2022SE |
| K202637 | F3D Corpectomy SystemMQP · Traditional | Corelink, LLC | 12/23/2020SE |
| K200235 | KONG-TL VBR System, KONG-C VBR SystemMQP · Traditional | Icotec AG | 05/29/2020SE |
| K193506 | NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemMQP · Special | Nu Vasive, Incorporated | 02/26/2020SE |
| K192117 | Small VBRMQP · Traditional | Ulrich GmbH & Co. KG | 11/01/2019SE |
| K190349 | MediExpand TL Expandable VBR SystemMQP · Traditional | Cmf Medicon Surgical, Inc. | 10/24/2019SE |
| K192214 | CarboClear VBR SystemMQP · Traditional | CarboFix Orthopedics , Ltd. | 10/11/2019SE |
| K183054 | SYNMESH SystemMQP · Traditional | Depuy Synthes Spine | 05/23/2019SE |
| K190147 | COLOSSEUM MeshMQP · Traditional | Globus Medical, Inc. | 05/08/2019SE |
| K183197 | PYRAMESH Implant SystemMQP · Traditional | Medtronic Sofamor Danek USA, Inc. | 04/04/2019SE |
| K183588 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemMQP · Special | Choicespine | 02/22/2019SE |
| K183510 | T2 STRATOSPHERE Expandable Corpectomy SystemMQP · Special | Medtronic Sofamor Danek USA, Inc. | 01/16/2019SE |
| K180665 | SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemMQP · Traditional | K2m, LLC | 11/28/2018SE |
| K181921 | Solidity Vertebral Body ReplacementMQP · Traditional | Ulrich Medical USA | 11/16/2018SE |
| K181328 | T2 STRATOSPHERE Expandable Corpectomy SystemMQP · Traditional | Medtronic Sofamor Danek USA, Inc. | 09/19/2018SE |
| K173982 | FORTIFY Corpectomy SpacersMQP · Traditional | Globus Medical, Inc. | 09/19/2018SE |
| K173787 | X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…MQP · Traditional | Medos International SARL | 06/11/2018SE |
| K173800 | Camber Spine Technologies SPIRA - V Open Matrix Corpectomy CageMQP · Traditional | Camber Spine Technologies | 02/02/2018SE |
| K172330 | Blustone Synergy Silica SystemMQP · Traditional | Blustone Synergy | 12/21/2017SE |
| K173125 | T2 STRATOSPHERE Expandable Corpectomy SystemMQP · Traditional | Medtronic Sofamor Danek | 12/20/2017SE |
| K162315 | FORTIFY Corpectomy SpacersMQP · Traditional | Globus Medical, Inc. | 11/09/2017SE |
| K172323 | Omnia Medical VBRMQP · Traditional | Omnia Medical, LLC | 10/26/2017SE |
| K171686 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemMQP · Traditional | Choicespine | 09/15/2017SE |
| K171704 | CAPRI Corpectomy Cage SystemMQP · Traditional | K2m | 08/31/2017SE |
| K162133 | VerteFIT Corpectomy Cage SystemMQP · Traditional | Ldr Spine USA, Inc. | 05/16/2017SE |
| K170055 | CAPRI Corpectomy Cage SystemMQP · Traditional | K2m | 04/13/2017SE |
| K170271 | NuVasive(r) Monolith Corpectomy SystemMQP · Traditional | Nu Vasive, Incorporated | 03/30/2017SE |
| K152460 | Rectangular Corpectomy CageMQP · Traditional | Amendia, Inc. | 12/22/2015SE |
| K151538 | NuVasive PEEK Corpectomy Railed SystemMQP · Traditional | Nu Vasive, Incorporated | 09/04/2015SE |
| K151167 | NuVasive PEEK Corpectomy SystemMQP · Traditional | Nu Vasive, Incorporated | 09/03/2015SE |
| K142005 | SpineFab Vertebral Body Replacement (VBR) SystemMQP · Traditional | Oxford Performance Materials | 07/10/2015SE |
| K142205 | NuVasive X-CORE(R) Expandable VBR SystemMQP · Traditional | Nuvasive, Inc. | 02/20/2015SE |
| K142996 | StaXx(R) XD SystemMQP · Traditional | Spine Wave, Inc. | 02/19/2015SE |
| K143490 | VERTA Corpectomy CageMQP · Traditional | Camber Spine | 01/26/2015SE |
| K142030 | Stgc-LordoticMQP · Traditional | Cardinal Spine, LLC | 01/23/2015SE |
| K142016 | CapriMQP · Traditional | K2m, Inc. | 11/06/2014SE |
| K142150 | Ais Modulift VBR SystemMQP · Traditional | Aesculap Implant System, Inc. | 10/29/2014SE |
| K140563 | Lateral VBR SystemMQP · Traditional | Nu Vasive, Incorporated | 08/07/2014SE |
| K133802 | Ais Modulift VBR SystemMQP · Traditional | Aesculap Implant System, Inc. | 04/17/2014SE |
| K123758 | Tasmin RMQP · Traditional | Signus Medizintechnik GmbH | 01/14/2014SE |
| K131724 | Pioneer Maxfuse Vertebral Body Replacement DeviceMQP · Traditional | Pioneer Surgical Technology, Inc. | 12/24/2013SE |
| K133207 | Staxx(R) SystemMQP · Special | Spine Wave, Inc. | 12/06/2013SE |
| K131888 | T2 XVBR Spinal System, T2 Altitude Expandable Corpectomy DeviceMQP · Traditional | Medtronic Sofamor Danek, Inc. | 09/23/2013SE |
| K122622 | EndurameshMQP · Special | Lucero Medical, LLC | 09/19/2012SE |
| K121889 | Staxx XD SystemMQP · Special | Spine Wave, Inc. | 08/29/2012SE |
| K121176 | STGCMQP · Traditional | Cardinal Spine, LLC | 08/17/2012SE |
| K121107 | Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)MQP · Special | Globus Medical, Inc. | 07/03/2012SE |
| K120570 | Choice Spine Vertebral Body Replacement (VBR) Device SystemMQP · Traditional | Choicespine, LP | 04/05/2012SE |
| K111294 | Santorini Spinal SystemMQP · Traditional | K2m, Inc. | 01/27/2012SE |
| K112429 | Giza(R) Vertebral Body ReplacementMQP · Traditional | Eden Spine, LLC | 01/26/2012SE |
| K111418 | Staxx(R) XD SystemMQP · Traditional | Spine Wave, Inc. | 12/13/2011SE |
| K103320 | Synthes XRLMQP · Traditional | Synthes Spine Co.Lp | 10/20/2011SE |
| K110153 | SFC Vertebral Body ReplacementMQP · Traditional | Konigsee Implantate GmbH | 10/12/2011SE |
| K112756 | Fortify(Tm) and Fortify(Tm)-R Corpectomy SpacersMQP · Special | Globus Medical, Inc. | 10/07/2011SE |
| K102315 | Staxx XDL SystemMQP · Traditional | Spine Wave, Inc. | 08/19/2011SE |
| K101886 | Dsc/Alf Spinal SystemMQP · Traditional | Sintea Plastek, LLC | 07/21/2011SE |
| K111469 | Staxxsd SystemMQP · Special | Spine Wave, Inc. | 07/19/2011SE |
| K110864 | Biospine VBR SystemMQP · Traditional | Aesculap Implant Systems, LLC | 06/15/2011SE |
| K102682 | Staxx(R) XD SystemMQP · Special | Spine Wave, Inc. | 11/30/2010SE |
| K100976 | T2 XVBR 1.5 Spinal SystemMQP · Traditional | Medtronic Sofamor Danek USA, Inc. | 10/21/2010SE |
| K101288 | Staxx XD SystemMQP · Traditional | Spine Wave, Inc. | 09/10/2010SE |
| K093207 | Enduramesh, Model 762.XXXMQP · Traditional | Lucero Medical, LLC | 04/26/2010SE |
| K093127 | Trabecular Metal (TM) Vertebral Body Replacement (VBR) System Instrument SetMQP · Traditional | Zimmer Trabecular Metal Technology | 03/04/2010SE |
| K083186 | Aesculap Hydrolift VBR SystemMQP · Traditional | Aesculap Implant System, Inc. | 03/04/2010SE |
| K091426 | Cervicore Corpectomy CageMQP · Traditional | Verticor, Ltd. | 12/23/2009SE |
| K091743 | Sec VBRMQP · Traditional | Innvotec Surgical, Inc. | 11/02/2009SE |
| K092336 | C-Thru Spinal SystemMQP · Traditional | Ebi, L.P. | 10/15/2009SE |
| K090841 | AddplusMQP · Traditional | Ulrich GmbH & Co. KG | 10/05/2009SE |
| K091946 | Vlift-S Vertebral Body Replacement System, Models 488812XX, 488814XX, 488816XX, 488818XXMQP · Traditional | Stryker Spine | 09/25/2009SE |
| K091883 | T2 Spinal SystemMQP · Traditional | Medtronic Sofamor Danek USA, Inc. | 09/21/2009SE |
| K091406 | Atlas Spine SpacerMQP · Traditional | Atlas Spine, LLC | 09/04/2009SE |
| K090315 | Staxx XD SystemMQP · Traditional | Spine Wave, Inc. | 09/03/2009SE |
| K090176 | Nuvasive Adjustable Vertebral Body Replacement SystemMQP · Special | Nuvasive, Inc. | 04/27/2009SE |
| K083857 | LDR Spine Roi-C ImplantMQP · Special | Ldr Spine USA | 02/12/2009SE |
| K082466 | Xycor Spinal ImplantMQP · Traditional | Vertebration,Inc | 01/09/2009SE |
| K082112 | T2 XVBR Spinal SystemMQP · Special | Medtronic Sofamor Danek | 08/27/2008SE |
| K081383 | Reliance VBS SystemMQP · Special | Reliance Medical Systems, LLC | 07/02/2008SE |
| K080971 | Spinesmith Cimplicity Spinal SystemMQP · Traditional | Spine Smith Partners L.P. | 07/02/2008SE |
| K081564 | Creaspine Supstance Vertebral Body Replacement System Line ExtensionMQP · Special | Creaspine | 06/30/2008SE |
| K072326 | Ostapek VBR SystemMQP · Traditional | Co-Ligne AG | 06/24/2008SE |
| K081332 | Athlet Vertebral Body Replacement SystemMQP · Special | Signus Medizintechnik GmbH | 06/10/2008SE |
| K080860 | Creaspine Supstance Small Vertebral Body Replacement SystemMQP · Traditional | Creaspine | 05/29/2008SE |
| K080728 | LDR Spine Roi-C ImplantMQP · Special | Ldr Spine USA | 05/29/2008SE |
| K080699 | Novel Spinal Spacer SystemMQP · Traditional | Alphatec Spine, Inc. | 05/21/2008SE |
| K080569 | LDR Spine Roi-T ImplantMQP · Special | Ldr Spine USA | 05/07/2008SE |
| K080568 | X-Mesh Expandable Cage SystemMQP · Special | Depuy Spine, Inc. | 05/01/2008SE |
| K080572 | LDR Spine Roi-A ImplantMQP · Special | Ldr Spine USA | 04/07/2008SE |
| K073502 | Vertebron VBR SystemMQP · Traditional | Vertebron, Inc. | 03/24/2008SE |
| K080349 | Kimba MiniMQP · Special | Signus Medizintechnik GmbH | 03/10/2008SE |
| K073649 | Bengal Stackable Cage SystemMQP · Special | Depuy Spine, Inc. | 01/25/2008SE |
| K080024 | Aleutian Spacer, Model K2-07-1004-01, K2-07-1005-01MQP · Special | K2m, Inc. | 01/24/2008SE |
| K073505 | Modification to Valeo VBRMQP · Special | Amedica Corp. | 01/09/2008SE |
| K072537 | Creaspine Supstance Vertebral Body Replacement SystemMQP · Traditional | Creaspine Sas | 12/18/2007SE |
| K073125 | Valeo VBRMQP · Special | Amedica Corp. | 12/05/2007SE |
| K071726 | ZumaMQP · Traditional | Seaspine, Inc. | 10/23/2007SE |
| K072029 | Phenix Vertebral Body ReplacementMQP · Traditional | New Business Development, LLC | 10/15/2007SE |
| K072465 | Niko Corpectomy SpacerMQP · Special | Globus Medical, Inc. | 10/04/2007SE |
| K063637 | Reliance VBS SystemMQP · Traditional | Reliance Medical Systems, LLC | 09/27/2007SE |
| K070754 | Trabecular Metal Vertebral Body Replacement (VBR), Model# 06-115, 06-155MQP · Traditional | Zimmer Trabecular Metal Technology | 08/31/2007SE |
| K072132 | LDR Spine Roi-T SystemMQP · Special | Ldr Spine USA | 08/30/2007SE |
| K071274 | Gso GS1 SpacerMQP · Traditional | Gold Standard Orthopedics, LLC | 08/24/2007SE |
| K071033 | T2 XVBR Spinal SystemMQP · Traditional | Medtronic Sofamor Danek | 08/14/2007SE |
| K071031 | Vu E*Pod Vertebral Body ReplacementMQP · Traditional | Theken Spine, LLC | 07/30/2007SE |
| K071497 | Atlas Spine Vertebral Body ReplacementMQP · Special | Atlas Spine, Inc. | 06/29/2007SE |
| K070786 | X-Pod Adjustable Vertebral Body ReplacementMQP · Traditional | Theken Spine, LLC | 06/28/2007SE |
| K063393 | Small Stature SpacersMQP · Traditional | Biomet Spine | 06/25/2007SE |
| K071372 | Modification to: Interplate VBR SystemMQP · Special | Rsb Spine, LLC | 06/11/2007SE |
| K070382 | Vista -S DeviceMQP · Traditional | Zimmer Trabecular Metal Technology | 05/30/2007SE |
| K070381 | Theken Vu Mesh VBR SystemMQP · Traditional | Theken Spine, LLC | 04/25/2007SE |
| K070082 | Xy Cor Spinal Implant for Minimal Invasive Spinal SurgeryMQP · Traditional | Vertebration,Inc | 04/20/2007SE |
| K070316 | Interplate VBR SystemMQP · Traditional | Rsb Spine, LLC | 04/19/2007SE |
| K070181 | Sintea Biotech Dsc/Alf Spinal System, DSC.XX.T5.XX, ALF.XX.T5.XXMQP · Traditional | Sintea Biotech, Inc. | 04/18/2007SE |
| K070218 | Vertiflex Octane PEEK Vertebral Body Replacement (PEEK VBR)MQP · Traditional | Vertiflex (Tm), Incorporated | 04/06/2007SE |
| K062083 | Synfix -LrMQP · Traditional | Synthes Spine Co.Lp | 04/03/2007SE |
| K070173 | Verte-Stack Spinal SystemMQP · Special | Medtronic Sofamor Danek, Inc. | 03/14/2007SE |
| K063464 | Atlas Spine Vertebral Body ReplacementMQP · Traditional | Atlas Spine, Inc. | 03/09/2007SE |
| K063491 | T2 Sceptor Spinal SystemMQP · Traditional | Medtronic Sofamor Danek | 03/05/2007SE |
| K063205 | Atlas Spine Vertebral Body ReplacementMQP · Traditional | Atlas Spine, LLC | 02/26/2007SE |
| K063399 | Aleutian Spacer SystemMQP · Special | K2m, Inc. | 02/23/2007SE |
| K062933 | Synthes Oracle SpacerMQP · Traditional | Synthes Spine Co.Lp | 01/31/2007SE |
| K062666 | Vusion TS, PS, and CS Partial Vertebral Body ReplacementsMQP · Traditional | Ortho Development Corp. | 01/25/2007SE |
| K062759 | Paramount VBR SystemMQP · Traditional | Innovative Spinal Technologies, Inc. | 01/12/2007SE |
| K061578 | SSP Vertebral Body ReplacementMQP · Traditional | Specialty Spine Products, LLC | 12/26/2006SE |
| K060416 | Obelisc Vertebral Body Replacement DeviceMQP · Traditional | Ulrich GmbH & Co. KG | 12/26/2006SE |
| K062151 | Box PEEK VBR SystemMQP · Traditional | Innovasis, Inc. | 12/22/2006SE |
| K061082 | Mobis Spinal ImplantMQP · Special | Signus Medizintechnik GmbH | 12/18/2006SE |
| K062810 | Solitaire Anterior Spinal SystemMQP · Special | Ebi, L.P. | 10/17/2006SE |
| K062133 | Modification to Verte-Stack Spinal SystemMQP · Special | Medtronic Spinal and Biologics Div | 09/26/2006SE |
| K061155 | Vista P Vertebral Body Replacement SystemMQP · Traditional | Zimmer Trabecular | 09/22/2006SE |
| K060762 | Aesculap PEEK Vertebral Body Replacement SystemMQP · Traditional | Aesculap, Inc. | 09/14/2006SE |
| K062427 | Verte-Stack Spinal SystemMQP · Traditional | Medtronic Sofamor Danek | 09/12/2006SE |
| K061891 | Synex IIMQP · Traditional | Synthes Spine Co.Lp | 08/18/2006SE |
| K061401 | Interplate VBR SystemMQP · Traditional | Rsb Spine, LLC | 08/18/2006SE |
| K062132 | Avs PL PEEK Spacer SystemMQP · Special | Stryker Spine | 08/16/2006SE |
| K062004 | Modification to Quantum Vertebral Body ReplacementMQP · Special | Quantum Orthopedics, Inc. | 08/15/2006SE |
| K061752 | Spinal USA VBR SystemMQP · Traditional | Spinal USA | 08/15/2006SE |
| K062073 | Verte-Stack Spinal SystemMQP · Special | Medtronic Sofamor Danek | 08/14/2006SE |
| K061938 | Verte-Stack Spinal SystemMQP · Special | Medtronic Sofamor Danek, Inc. | 08/09/2006SE |
| K061836 | Avs Asl PEEK Spacer SystemMQP · Special | Stryker Spine | 08/03/2006SE |
| K061151 | Pioneer Vertebral Spacer (Vertebral Spacer)MQP · Traditional | Pioneer Surgical Technology | 07/24/2006SE |
| K061576 | Modification to Quantum Vertebral Body Replacement SystemMQP · Special | Quantum Orthopedics, Inc. | 07/03/2006SE |
| K061380 | Retain Radiolucent SpacerMQP · Special | Globus Medical, Inc. | 06/08/2006SE |
| K061016 | Ebi Esl Peek-Optima Spine SystemMQP · Special | Ebi, L.P. | 06/08/2006SE |
| K060916 | Atlas Spinal Cage, Models SC-150-007, 009, 011, 013, 015, 017.MQP · Traditional | Spinal Edge, LLC | 06/08/2006SE |
| K060506 | Stryker Spine Vlift Vertebral Body Replacement SystemMQP · Traditional | Stryker Spine | 05/25/2006SE |
| K060665 | Xpand Radiolucent Corpectomy SpacerMQP · Special | Globus Medical, Inc. | 05/10/2006SE |
| K052670 | Staxx XD SystemMQP · Traditional | Spine Wave, Inc. | 04/27/2006SE |
| K060719 | Modification to Verte-Stack Spinal SystemMQP · Special | Medtronic Sofamor Danek | 04/14/2006SE |
| K052641 | Modification to: Quantum Vertebral Body ReplacementMQP · Special | Quantum Orthopedics, Inc. | 04/12/2006SE |
| K060350 | Construx Pl/Tl PEEK Partial VBR SystemMQP · Special | Blackstone Medical, Inc. | 02/24/2006SE |
| K051525 | Arx Spinal SystemMQP · Traditional | Amedica Corp. | 02/17/2006SE |
| K053508 | Synfix-LrMQP · Traditional | Synthes Spine Co.Lp | 02/13/2006SE |
| K053292 | Davantis/Antelys Vertebral Body ReplacementsMQP · Special | Scient'X USA, Inc. | 01/19/2006SE |
| K052170 | Seaspine VBR SystemMQP · Traditional | Seaspine, Inc. | 12/21/2005SE |
| K051781 | Graftcage TLXMQP · Traditional | Osteotech, Inc. | 12/16/2005SE |
| K052210 | Nuvasive Coroent Extensure SystemMQP · Special | Nuvasive, Inc. | 12/12/2005SE |
| K053080 | Graftcage AcxMQP · Traditional | Osteotech, Inc. | 12/01/2005SE |
| K052950 | The Zimmer TMT Trabecular Metal Vertebral Body Replacement SystemMQP · Special | Zimmer Trabecular | 11/16/2005SE |
| K052931 | Modification to Verte-Stack Spinal SystemMQP · Special | Medtronic Sofamor Danek | 11/16/2005SE |
| K051205 | Stryker Spine Avs Asl PEEK SpacerMQP · Traditional | Stryker Spine | 11/04/2005SE |
| K052533 | Kimba Spinal ImplantMQP · Traditional | Signus Medizintechnik GmbH | 11/03/2005SE |
| K052746 | Concorde VBR Spinal SystemMQP · Special | Depuy Spine, Inc. | 10/21/2005SE |
| K052384 | Lanx VBR SystemMQP · Traditional | Lanx, LLC | 10/07/2005SE |
| K052261 | Modification to: Verte-Stack Spinal SystemMQP · Special | Medtronic Sofamor Danek USA, Inc. | 10/07/2005SE |
| K050997 | Expanse Vertebral Body Replacement DeviceMQP · Traditional | Flexuspine, Inc. | 10/07/2005SE |
| K051978 | Trabecular Metal Vertebral Body ReplacementMQP · Special | Implex Corp. | 09/23/2005SE |
| K052096 | Nubic Spinal ImplantMQP · Special | Signus Medical, LLC | 08/16/2005SE |
| K051454 | Aleutian Spacer SystemMQP · Traditional | K2m, LLC | 07/27/2005SE |
| K051659 | Semial Spinal ImplantMQP · Special | Signus Medizintechnik GmbH | 07/13/2005SE |
| K050449 | Quantum Vertebral Body ReplacementMQP · Traditional | Quantum Orthopedics, Inc. | 07/07/2005SE |
| K043479 | Mc+ Partial VBRMQP · Traditional | Ldr Spine USA | 06/30/2005SE |
| K051027 | Stalif TTMQP · Traditional | Surgicraft , Ltd. | 06/29/2005SE |
| K043349 | Open Radiotransparent Intersomatic Implant (Roi)MQP · Traditional | Ldr Spine USA | 06/29/2005SE |
| K051196 | Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and 06-166-051X1MQP · Special | Implex Corp. | 06/17/2005SE |
| K051246 | Construx Mini PEEK VBR SystemMQP · Traditional | Blackstone Medical, Inc. | 06/14/2005SE |
| K051105 | Basis Vertebral Body SpacerMQP · Traditional | Medtronic Sofamor Danek | 06/09/2005SE |
| K050861 | PEEK CasMQP · Special | Interpore Cross Intl. | 05/27/2005SE |
| K050348 | Co Vertebral Body ReplacementMQP · Special | Scient'X | 05/27/2005SE |
| K050850 | Xpand Corpectomy SpacerMQP · Special | Globus Medical, Inc. | 05/26/2005SE |
| K051000 | Fortitude Vue Vertebral Body Replacement DeviceMQP · Special | Spinal Concepts, Inc. | 05/19/2005SE |
| K050058 | Theken Reveal VBR SystemMQP · Traditional | Theken Surgical,Llc | 05/17/2005SE |
| K050553 | Novel VBR Spinal SystemMQP · Special | Alphatec/Nexmed | 04/18/2005SE |
| K050624 | Stryker Spine Avs PL PEEK SpacerMQP · Traditional | Stryker Spine | 04/11/2005SE |
| K042600 | Stansion MatrixMQP · Traditional | Spineworks, LLC | 02/18/2005SE |
| K042571 | Stryker Spine Avs TL PEEK SpacerMQP · Traditional | Stryker Spine | 02/11/2005SE |
| K043405 | Nuvasive Coroent SystemMQP · Traditional | Nuvasive, Inc. | 02/07/2005SE |
| K043316 | Rabea Spinal ImplantMQP · Traditional | Signus Medizintechnik GmbH | 02/07/2005SE |
| K041798 | Atalia Titanium Surgical MeshMQP · Traditional | Us Spinal Technologies, LLC | 02/07/2005SE |
| K043206 | Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)MQP · Traditional | Pioneer Surgical Technology | 01/21/2005SE |
| K043566 | Modification to Verte-Stack Spinal SystemMQP · Special | Medtronic Sofamor Danek | 01/07/2005SE |
| K043561 | Modification to Verte-Stack Spinal SystemMQP · Special | Medtronic Sofamor Danek | 12/29/2004SE |
| K042714 | Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4MQP · Traditional | Spine Next America Corporation | 12/29/2004SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0738-2023 Class II | X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with…Potential that insert will be unable to disengage from the vertebral body replacement device/implant | NuVasive Inc | 11/10/2022Open, Classified |
| Z-0417-2021 Class III | 3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usage: is a…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | Synthes (USA) Products LLC | 09/21/2020Terminated |
| Z-0416-2021 Class III | STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - Product Usage: is a vertebral…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | Synthes (USA) Products LLC | 09/21/2020Terminated |
| Z-0415-2021 Class III | STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a vertebral…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | Synthes (USA) Products LLC | 09/21/2020Terminated |
| Z-0414-2021 Class III | END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 - Product…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | Synthes (USA) Products LLC | 09/21/2020Terminated |
| Z-0413-2021 Class III | END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495-396 - Product…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | Synthes (USA) Products LLC | 09/21/2020Terminated |
| Z-0412-2021 Class III | END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495.394 - Product…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | Synthes (USA) Products LLC | 09/21/2020Terminated |
| Z-0411-2021 Class III | END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 - Product…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | Synthes (USA) Products LLC | 09/21/2020Terminated |
| Z-0410-2021 Class III | END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - Product Usage: is a vertebral…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | Synthes (USA) Products LLC | 09/21/2020Terminated |
| Z-0409-2021 Class III | END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - Product Usage: is a vertebral…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | Synthes (USA) Products LLC | 09/21/2020Terminated |
| Z-0408-2021 Class III | END RING 10MM DIA/0 DEG (TI) Product Number: 495.384 - Product Usage: is a vertebral…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | Synthes (USA) Products LLC | 09/21/2020Terminated |
| Z-0407-2021 Class III | SYNMESH 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - Product Usage: is a…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | Synthes (USA) Products LLC | 09/21/2020Terminated |
| Z-0406-2021 Class III | SYNMESH 17MM X 22MM 88MM HEIGHT (TI) Product Number: 495-374 - Product Usage: is a…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | Synthes (USA) Products LLC | 09/21/2020Terminated |
| Z-0405-2021 Class III | SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: is a…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | Synthes (USA) Products LLC | 09/21/2020Terminated |
| Z-0404-2021 Class III | SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - Product Usage: is a…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | Synthes (USA) Products LLC | 09/21/2020Terminated |
| Z-0403-2021 Class III | DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Product Usage:…Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM… | Synthes (USA) Products LLC | 09/21/2020Terminated |
| Z-2072-2017 Class II | GIZA Vertebral Body ReplacementComplaints that implants have been disassembled by surgeons because of unscrewing completely the locking… | Eden Spine Europe SA | 03/17/2017Terminated |
| Z-1681-2014 Class II | Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL…Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect… | Synthes, Inc. | 04/08/2014Terminated |
| Z-1616-2016 Class II | Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate…The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc… | Atlas Spine, Inc. | 07/26/2013Terminated |
| Z-0535-2013 Class II | Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton…Titan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. The labeling accompanying this… | Titan Spine, LLC | 10/19/2012Terminated |
| Z-2368-2012 Class II | Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a vertebral body…The firm voluntarily recalled the device after they discovered that the sterilization recommendations on the… | Lucero Medical LLC | 07/15/2012Terminated |
| Z-1059-2012 | ENDURAMESH CORPECTOMY SPACER SYSTEM 013MM, 017MM, 023MM by varying heights. Dist. By:…During an FDA inspection the firm was informed that the device marketed is not the device cleared for the… | Lucero Medical LLC | 01/11/2012Terminated |
| Z-2202-2011 | Theken L"POD" Titanium Vertebral Body Replacement System, Vu c"POD" PEEK-Optima…Certain Theken Spine Vertebral Body Replacement Systems were distributed (i) without certain components… | Integra LifeSciences Corp. | 01/18/2011Terminated |
| Z-1475-2011 | Vu a-POD Intervertebral Body Fusion Device. Packaged as surgical kits containing all…The IFU provided with the device contains incorrect information in the Indications for Use Section, stating… | Integra LifeSciences Corp. | 10/19/2010Terminated |
| Z-2583-2010 | SynFix-LR Spinal Implant System (Implant Holder for SynFix-LR and surgical technique…A potential for the implant holder tip to break off and lodge in the SynFix-LR implant, which pose a… | Synthes USA (HQ), Inc. | 07/23/2010Terminated |
| Z-0641-2010 | Orthofix Spinal Implants; Pillar SA PEEK Spacer System Instrument Case. Case contents:…The Pillar SA Implant Insertion Instrument 49-1100 may experience resistance in turning the activation knob… | Orthofix, Inc | 11/19/2009Terminated |
| Z-0118-2010 | Synthes USA, TI Synex (TM) II Central Body 97mm - 123mm, Catalog number 04.808.011.…loss of device height | Synthes USA (HQ), Inc. | 09/14/2009Terminated |
| Z-0117-2010 | Synthes USA, TI Synex (TM) II Central Body 84mm - 110mm, Catalog number 04.808.010.…loss of device height | Synthes USA (HQ), Inc. | 09/14/2009Terminated |
| Z-0116-2010 | Synthes USA, TI Synex (TM) II Central Body 71mm - 97mm, Catalog number 04.808.009.…loss of device height | Synthes USA (HQ), Inc. | 09/14/2009Terminated |
| Z-0115-2010 | Synthes USA, TI Synex (TM) II Central Body 58mm - 84mm, Catalog number 04.808.008.…loss of device height | Synthes USA (HQ), Inc. | 09/14/2009Terminated |
| Z-0114-2010 | Synthes USA, TI Synex (TM) II Central Body 45mm - 71mm, Catalog number 04.808.007.…loss of device height | Synthes USA (HQ), Inc. | 09/14/2009Terminated |
| Z-0113-2010 | Synthes USA, TI Synex (TM) II Central Body 37mm - 52mm, Catalog number 04.808.006.…loss of device height | Synthes USA (HQ), Inc. | 09/14/2009Terminated |
| Z-0112-2010 | Synthes USA, TI Synex (TM) II Central Body 29mm - 44mm, Catalog number 04.808.005.…loss of device height | Synthes USA (HQ), Inc. | 09/14/2009Terminated |
| Z-0111-2010 | Synthes USA, TI Synex (TM) II Central Body 25mm - 33mm, Catalog number 04.808.004.…loss of device height | Synthes USA (HQ), Inc. | 09/14/2009Terminated |
| Z-0110-2010 | Synthes USA, TI Synex (TM) II Central Body 21mm - 29mm, Catalog number 04.808.003.…loss of device height | Synthes USA (HQ), Inc. | 09/14/2009Terminated |
| Z-0109-2010 | Synthes USA, TI Synex (TM) II Central Body 17mm - 25mm, Catalog number 04.808.002.…loss of device height | Synthes USA (HQ), Inc. | 09/14/2009Terminated |
| Z-0108-2010 | Synthes USA, TI Synex (TM) II Central Body 14mm - 19mm, Catalog number 04.808.001.…loss of device height | Synthes USA (HQ), Inc. | 09/14/2009Terminated |
| Z-2311-2009 | Bone Screw 7MM (D) x 35 MM (L) Telescopic Plate Spacer Thoracolumbar Spinal System; Made…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-2310-2009 | Bone Screw 6MM (D) x 35MM (L) Telescopic Plate Spacer, Thoracolumbar Spinal System Made…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-0508-2009 | Novel PEEK VBR XS 16-22 MM, S-5, 26MM, Part Numbers : 64753-126. Indicated for use in…Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong… | Alphatec Spine, Inc. | 08/16/2007Terminated |
| Z-0507-2009 | Novel PEEK VBR XS 16-22 MM, S-5, 20MM, Part Number: 64733-120. Indicated for use in the…Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong… | Alphatec Spine, Inc. | 08/16/2007Terminated |
| Z-0355-2007 | TraXis Fixed Rasp in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; for use with TraXis vertebral…Tip of devices may dislodge while in use during surgery. | Abbott Spine | 11/07/2006Terminated |
| Z-0354-2007 | TraXis Fixed Trial in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; part of TraXis vertebral…Tip of devices may dislodge while in use during surgery. | Abbott Spine | 11/07/2006Terminated |