K261008
- 510(k) number
- K261008
- Device name
- 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 Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute
- Applicant
- Stryker Spine NJ · US
- Product code
- MQV — Filler, Bone Void, Calcium Compound
- Decision date
- 2026-04-24
- Date received
- 2026-03-26
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K261008.pdf
Official FDA record: K261008
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.