K233198
- 510(k) number
- K233198
- Device name
- OSSIOfiber® Threaded Trimmable Fixation Nails
- Applicant
- OSSIO , Ltd. IL
- Product code
- HWC — Screw, Fixation, Bone
- Decision date
- 2024-03-08
- Date received
- 2023-09-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K233198.pdf
Official FDA record: K233198
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.