K253147
- 510(k) number
- K253147
- Device name
- FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute FIBERGRAFT BG Matrix Bone Graft Substitute
- Applicant
- Prosidyan, Inc. NJ · US
- Product code
- MQV — Filler, Bone Void, Calcium Compound
- Decision date
- 2025-10-22
- Date received
- 2025-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253147.pdf
Official FDA record: K253147
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.