Product code MQP
- Device name
- Spinal Vertebral Body Replacement Device
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3060
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253158 | VyBrate™ VBR System | Vy Spine, LLC | 2026-01-07 |
| K241468 | Vertiwedge® Intraosseous System | Foundation Surgical Group, Inc. | 2024-11-07 |
| K232790 | KONG®-TL VBR System and KONG® C VBR System | Icotec AG | 2024-04-04 |
| K233359 | DOMINION Expandable Corpectomy System | Astura Medical | 2024-03-08 |
| K231134 | VerteLoc Spinal System | Signature Orthopaedics Pty, Ltd. | 2024-02-13 |
| K232173 | Ascend VBR System, Ascend NanoTec VBR System | Alphatec Spine, Inc. | 2023-10-06 |
| K211892 | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) | Arftx Medical, LLC | 2022-10-06 |
| K202637 | F3D Corpectomy System | Corelink, LLC | 2020-12-23 |
| K200235 | KONG-TL VBR System, KONG-C VBR System | Icotec AG | 2020-05-29 |
| K193506 | NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System | Nu Vasive, Incorporated | 2020-02-26 |
| K192117 | Small VBR™ | Ulrich GmbH & Co. KG | 2019-11-01 |
| K190349 | MediExpand TL Expandable VBR System | Cmf Medicon Surgical, Inc. | 2019-10-24 |
| K192214 | CarboClear VBR System | CarboFix Orthopedics , Ltd. | 2019-10-11 |
| K183054 | SYNMESH System | Depuy Synthes Spine | 2019-05-23 |
| K190147 | COLOSSEUM Mesh | Globus Medical, Inc. | 2019-05-08 |
| K183197 | PYRAMESH™ Implant System | Medtronic Sofamor Danek USA, Inc. | 2019-04-04 |
| K183588 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) System | Choicespine | 2019-02-22 |
| K183510 | T2 STRATOSPHERE Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. | 2019-01-16 |
| K180665 | SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System | K2m, LLC | 2018-11-28 |
| K181921 | Solidity Vertebral Body Replacement | Ulrich Medical USA | 2018-11-16 |
| K181328 | T2 STRATOSPHERE™ Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. | 2018-09-19 |
| K173982 | FORTIFY Corpectomy Spacers | Globus Medical, Inc. | 2018-09-19 |
| K173787 | X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve... | Medos International SARL | 2018-06-11 |
| K173800 | Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage | Camber Spine Technologies | 2018-02-02 |
| K172330 | Blustone Synergy Silica System | Blustone Synergy | 2017-12-21 |
| K173125 | T2 STRATOSPHERE™ Expandable Corpectomy System | Medtronic Sofamor Danek | 2017-12-20 |
| K162315 | FORTIFY Corpectomy Spacers | Globus Medical, Inc. | 2017-11-09 |
| K172323 | Omnia Medical VBR | Omnia Medical, LLC | 2017-10-26 |
| K171686 | Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System | Choicespine | 2017-09-15 |
| K171704 | CAPRI Corpectomy Cage System | K2m | 2017-08-31 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840283403460 | LumiVy™ | VY SPINE LLC | 2026-06-05 |
| 00763000857844 | T2 STRATOSPHERE™ Expandable Corpectomy System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-06-01 |
| 00763000857943 | T2 STRATOSPHERE™ Expandable Corpectomy System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-06-01 |
| 00763000857998 | T2 STRATOSPHERE™ Expandable Corpectomy System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-06-01 |
| 07613153046424 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046585 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046462 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046479 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046486 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046493 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046509 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046516 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046523 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046530 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046547 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046554 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046561 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046394 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046370 | AVS PL | Stryker Corporation | 2015-09-14 |
| 07613153046349 | AVS PL | Stryker Corporation | 2015-09-14 |
| 07613153046332 | AVS PL | Stryker Corporation | 2015-09-14 |
| 07613153046325 | AVS PL | Stryker Corporation | 2015-09-14 |
| 07613153046318 | AVS PL | Stryker Corporation | 2015-09-14 |
| 07613153046301 | AVS PL | Stryker Corporation | 2015-09-14 |
| 07613153046295 | AVS PL | Stryker Corporation | 2015-09-14 |
| 07613153046288 | AVS PL | Stryker Corporation | 2015-09-14 |
| 07613153046233 | AVS PL | Stryker Corporation | 2015-09-14 |
| 07613153046226 | AVS PL | Stryker Corporation | 2015-09-14 |
| 07613153046219 | AVS PL | Stryker Corporation | 2015-09-14 |
| 07613153046202 | AVS PL | Stryker Corporation | 2015-09-14 |