K242280 is an FDA 510(k) clearance for the Vitoss? BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss? BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma? Bioactive Bone Graft Substitute,Vitoss? BA2X Bioactive Bone Graft Substitute, Vitoss? Bioactive Bone Graft Substitute Pack,Vitoss? Bioactive Bone Graft Substitute, Vitoss? Foam Bone Graft Substitute, Vitoss? Bone Graft Substitute Filled Canister, Vitoss? Bone Graft Substitute, Vitoss? Bone Graft Substitute - Synthetic Cancellous Chips. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).
Submitted by Stryker Spine (Allendale, US). The FDA issued a Cleared decision on August 29, 2024, 27 days after receiving the submission on August 2, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3045.
| 510(k) Number | K242280 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2024 |
| Decision Date | August 29, 2024 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MQV — Filler, Bone Void, Calcium Compound |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3045 |