K243658
- 510(k) number
- K243658
- Device name
- TMC Compression Implant System
- Applicant
- Treace Medical Concepts FL · US
- Product code
- JDR — Staple, Fixation, Bone
- Decision date
- 2024-12-26
- Date received
- 2024-11-27
- 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: K243658.pdf
Official FDA record: K243658
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.