K260361
- 510(k) number
- K260361
- Device name
- Treace Medical Concepts (TMC) Screw Fixation System
- Applicant
- Treace Medical Concepts, Inc. FL · US
- Product code
- HWC — Screw, Fixation, Bone
- Decision date
- 2026-03-06
- Date received
- 2026-02-04
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K260361.pdf
Official FDA record: K260361
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.