K231272
- 510(k) number
- K231272
- Device name
- OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail
- Applicant
- OSSIO , Ltd. IL
- Product code
- HTY — Pin, Fixation, Smooth
- Decision date
- 2023-12-01
- Date received
- 2023-05-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K231272.pdf
Official FDA record: K231272
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.