K242671
- 510(k) number
- K242671
- Device name
- Treace Medical Concepts (TMC) Screw Fixation System
- Applicant
- Treace Medical Concepts, Inc. FL · US
- Product code
- HWC — Screw, Fixation, Bone
- Decision date
- 2024-10-04
- Date received
- 2024-09-06
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.6 MB · U.S. public domain
Also available from FDA: K242671.pdf
Official FDA record: K242671
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.