MQP — Spinal Vertebral Body Replacement Device Class II
FDA Device Classification
Classification Details
- Product Code
- MQP
- Device Class
- Class II
- Regulation Number
- 888.3060
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K253158 | vy spine | VyBrate VBR System | January 7, 2026 |
| K241468 | foundation surgical group | Vertiwedge® Intraosseous System | November 7, 2024 |
| K232790 | icotec | KONG®-TL VBR System and KONG® C VBR System | April 4, 2024 |
| K233359 | astura medical | DOMINION Expandable Corpectomy System | March 8, 2024 |
| K231134 | signature orthopaedics pty | VerteLoc Spinal System | February 13, 2024 |
| K232173 | alphatec spine | Ascend VBR System, Ascend NanoTec VBR System | October 6, 2023 |
| K211892 | arftx medical | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) | October 6, 2022 |
| K202637 | corelink | F3D Corpectomy System | December 23, 2020 |
| K200235 | icotec | KONG-TL VBR System, KONG-C VBR System | May 29, 2020 |
| K193506 | nu vasive, incorporated | NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable | February 26, 2020 |
| K192117 | ulrich gmbh and co. kg | Small VBR | November 1, 2019 |
| K190349 | cmf medicon surgical | MediExpand TL Expandable VBR System | October 24, 2019 |
| K192214 | carbofix orthopedics | CarboClear VBR System | October 11, 2019 |
| K183054 | depuy synthes spine | SYNMESH System | May 23, 2019 |
| K190147 | globus medical | COLOSSEUM Mesh | May 8, 2019 |
| K183197 | medtronic sofamor danek usa | PYRAMESH Implant System | April 4, 2019 |
| K183588 | choicespine | Choice Spine Hawkeye Vertebral Body Replacement (VBR) System | February 22, 2019 |
| K183510 | medtronic sofamor danek usa | T2 STRATOSPHERE Expandable Corpectomy System | January 16, 2019 |
| K180665 | k2m | SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System | November 28, 2018 |
| K181921 | ulrich medical usa | Solidity Vertebral Body Replacement | November 16, 2018 |