510(k) K232387
K232387 is an FDA 510(k) premarket notification submitted by Treace Medical Concepts for the device "Treace Medical Concepts (TMC) Compression Implant System". The FDA issued a decision of Substantially Equivalent on August 28, 2023. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Treace Medical Concepts has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 2023
- Date Received
- August 9, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type