MQP — Spinal Vertebral Body Replacement Device Class II
FDA product code MQP covers "Spinal Vertebral Body Replacement Device", a Class II medical device regulated under 21 CFR 888.3060. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K261031 | signus medinzintechnik | POSEIDON ST | July 10, 2026 |
| 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 |