MQP
- Product code
- MQP
- Device name
- Spinal Vertebral Body Replacement Device
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3060
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 8
- Summaries archived here
- 7 (direct download)
- 510(k) clearances (all years, FDA)
- 279 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261810 | 2026-07-31 | Foundation Surgical Group | Vertiwedge® Intraosseous System | |
| K261031 | 2026-07-10 | Signus Medinzintechnik GmbH | POSEIDON ST | |
| K253158 | 2026-01-07 | Vy Spine, LLC | VyBrate VBR System | |
| K241468 | 2024-11-07 | Foundation Surgical Group, Inc. | Vertiwedge® Intraosseous System | |
| K232790 | 2024-04-04 | Icotec AG | KONG®-TL VBR System and KONG® C VBR System | FDA |
| K233359 | 2024-03-08 | Astura Medical | DOMINION Expandable Corpectomy System | |
| K231134 | 2024-02-13 | Signature Orthopaedics Pty, Ltd. | VerteLoc Spinal System | |
| K232173 | 2023-10-06 | Alphatec Spine, Inc. | Ascend VBR System, Ascend NanoTec VBR System |
Official FDA classification page: MQP
Classification and pathway per current FDA publications. Data from openFDA (CC0).