K252022
- 510(k) number
- K252022
- Device name
- OSSIOfiber® Interference Screw
- Applicant
- OSSIO , Ltd. IL
- Product code
- MAI — Fastener, Fixation, Biodegradable, Soft Tissue
- Decision date
- 2025-08-19
- Date received
- 2025-06-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252022.pdf
Official FDA record: K252022
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.