K251720
- 510(k) number
- K251720
- Device name
- OsteoFlo HydroFiber
- Applicant
- SurGenTec, LLC FL · US
- Product code
- MQV — Filler, Bone Void, Calcium Compound
- Decision date
- 2025-07-02
- Date received
- 2025-06-04
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K251720.pdf
Official FDA record: K251720
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.