K254077
- 510(k) number
- K254077
- Device name
- OSSIOfiber® Threaded Trimmable Fixation Nail
- Applicant
- OSSIO , Ltd. IL
- Product code
- HWC — Screw, Fixation, Bone
- Decision date
- 2026-05-01
- Date received
- 2025-12-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K254077.pdf
Official FDA record: K254077
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.