K243949
- 510(k) number
- K243949
- Device name
- OsteoFlo HydroFiber
- Applicant
- SurGenTec, LLC FL · US
- Product code
- MQV — Filler, Bone Void, Calcium Compound
- Decision date
- 2025-05-28
- Date received
- 2024-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K243949.pdf
Official FDA record: K243949
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.