510(k) K222564
K222564 is an FDA 510(k) premarket notification submitted by Treace Medical Concepts, Inc. for the device "Treace Medical Concepts (TMC) Hammertoe Fixation System". The FDA issued a decision of Substantially Equivalent on November 15, 2022. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Treace Medical Concepts, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 15, 2022
- Date Received
- August 24, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type