Panels › Orthopedic › Product code MQP · Class 2
Spinal Vertebral Body Replacement Device
Regulation 888.3060
3510(k)s in 12 months (279 all time)
0recalls in 12 months (46 all time)
42recalls that name a 510(k)
Top companies in MQP
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek | 36 | 0 |
| Synthes (USA) Products LLC | 0 | 15 |
| Synthes USA (HQ), Inc. | 0 | 12 |
| Globus Medical, Inc. | 11 | 0 |
| Interpore Cross Intl. | 10 | 0 |
| Spine Wave, Inc. | 10 | 0 |
| Depuyacromed | 8 | 0 |
| Ebi, L.P. | 6 | 2 |
| Implex Corp. | 8 | 0 |
| K2m | 8 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 31, 2026 | K261810 | Vertiwedge® Intraosseous System Foundation Surgical Group | MQP |
| Jul 10, 2026 | K261031 | POSEIDON ST Signus Medinzintechnik GmbH, DE | MQP |
| Jan 7, 2026 | K253158 | VyBrate VBR System Vy Spine, LLC | MQP |
| Nov 7, 2024 | K241468 | Vertiwedge® Intraosseous System Foundation Surgical Group, Inc. | MQP |
| Apr 4, 2024 | K232790 | KONG®-TL VBR System and KONG® C VBR System Icotec AG, CH | MQP |
| Mar 8, 2024 | K233359 | DOMINION Expandable Corpectomy System Astura Medical | MQP |
| Feb 13, 2024 | K231134 | VerteLoc Spinal System Signature Orthopaedics Pty, Ltd., AU | MQP |
| Oct 6, 2023 | K232173 | Ascend VBR System, Ascend NanoTec VBR System Alphatec Spine, Inc. | MQP |
| Oct 6, 2022 | K211892 | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) Arftx Medical, LLC | MQP |
| Dec 23, 2020 | K202637 | F3D Corpectomy System Corelink, LLC | MQP |
| May 29, 2020 | K200235 | KONG-TL VBR System, KONG-C VBR System Icotec AG, CH | MQP |
| Feb 26, 2020 | K193506 | NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System Nu Vasive, Incorporated | MQP |
| Nov 1, 2019 | K192117 | Small VBR Ulrich GmbH & Co. KG, DE | MQP |
| Oct 24, 2019 | K190349 | MediExpand TL Expandable VBR System Cmf Medicon Surgical, Inc. | MQP |
| Oct 11, 2019 | K192214 | CarboClear VBR System CarboFix Orthopedics , Ltd., IL | MQP |
| May 23, 2019 | K183054 | SYNMESH System Depuy Synthes Spine | MQP |
| May 8, 2019 | K190147 | COLOSSEUM Mesh Globus Medical, Inc. | MQP |
| Apr 4, 2019 | K183197 | PYRAMESH Implant System Medtronic Sofamor Danek USA, Inc. | MQP |
| Feb 22, 2019 | K183588 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) System Choicespine | MQP |
| Jan 16, 2019 | K183510 | T2 STRATOSPHERE Expandable Corpectomy System Medtronic Sofamor Danek USA, Inc. | MQP |
| Nov 28, 2018 | K180665 | SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System K2m, LLC | MQP |
| Nov 16, 2018 | K181921 | Solidity Vertebral Body Replacement Ulrich Medical USA | MQP |
| Sep 19, 2018 | K181328 | T2 STRATOSPHERE Expandable Corpectomy System Medtronic Sofamor Danek USA, Inc. | MQP |
| Sep 19, 2018 | K173982 | FORTIFY Corpectomy Spacers Globus Medical, Inc. | MQP |
| Jun 11, 2018 | K173787 | X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BEN Medos International SARL, CH | MQP |
| Feb 2, 2018 | K173800 | Camber Spine Technologies SPIRA - V Open Matrix Corpectomy Cage Camber Spine Technologies | MQP |
| Dec 21, 2017 | K172330 | Blustone Synergy Silica System Blustone Synergy | MQP |
| Dec 20, 2017 | K173125 | T2 STRATOSPHERE Expandable Corpectomy System Medtronic Sofamor Danek | MQP |
| Nov 9, 2017 | K162315 | FORTIFY Corpectomy Spacers Globus Medical, Inc. | MQP |
| Oct 26, 2017 | K172323 | Omnia Medical VBR Omnia Medical, LLC | MQP |
| Sep 15, 2017 | K171686 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) System Choicespine | MQP |
| Aug 31, 2017 | K171704 | CAPRI Corpectomy Cage System K2m | MQP |
| May 16, 2017 | K162133 | VerteFIT Corpectomy Cage System Ldr Spine USA, Inc. | MQP |
| Apr 13, 2017 | K170055 | CAPRI Corpectomy Cage System K2m | MQP |
| Mar 30, 2017 | K170271 | NuVasive(r) Monolith Corpectomy System Nu Vasive, Incorporated | MQP |
| Dec 22, 2015 | K152460 | Rectangular Corpectomy Cage Amendia, Inc. | MQP |
| Sep 4, 2015 | K151538 | NuVasive PEEK Corpectomy Railed System Nu Vasive, Incorporated | MQP |
| Sep 3, 2015 | K151167 | NuVasive PEEK Corpectomy System Nu Vasive, Incorporated | MQP |
| Jul 10, 2015 | K142005 | SpineFab Vertebral Body Replacement (VBR) System Oxford Performance Materials | MQP |
| Feb 20, 2015 | K142205 | NuVasive X-CORE(R) Expandable VBR System Nuvasive, Inc. | MQP |
| Feb 19, 2015 | K142996 | StaXx(R) XD System Spine Wave, Inc. | MQP |
| Jan 26, 2015 | K143490 | VERTA Corpectomy Cage Camber Spine | MQP |
| Jan 23, 2015 | K142030 | STGC-LORDOTIC Cardinal Spine, LLC | MQP |
| Nov 6, 2014 | K142016 | CAPRI K2m, Inc. | MQP |
| Oct 29, 2014 | K142150 | AIS MODULIFT VBR SYSTEM Aesculap Implant System, Inc. | MQP |
| Aug 7, 2014 | K140563 | LATERAL VBR SYSTEM Nu Vasive, Incorporated | MQP |
| Apr 17, 2014 | K133802 | AIS MODULIFT VBR SYSTEM Aesculap Implant System, Inc. | MQP |
| Jan 14, 2014 | K123758 | TASMIN R Signus Medizintechnik GmbH | MQP |
| Dec 24, 2013 | K131724 | PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE Pioneer Surgical Technology, Inc. | MQP |
| Dec 6, 2013 | K133207 | STAXX(R) SYSTEM Spine Wave, Inc. | MQP |
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