510(k) K222645
K222645 is an FDA 510(k) premarket notification submitted by Treace Medical Concepts for the device "Treace Medical Concepts (TMC) Implant Fixation System". The FDA issued a decision of Substantially Equivalent on November 21, 2022. 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
- November 21, 2022
- Date Received
- September 1, 2022
- Clearance Type
- Traditional
- 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