Clearance Summary
Treace Medical Concepts (TMC) Screw Fixation System received FDA 510(k) clearance under submission number K213036, sponsored by Treace Medical Concepts, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2021-10-21.
- Submission: K213036
- Applicant / Sponsor: Treace Medical Concepts, Inc.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2021-10-21
Classification & Regulation
This clearance is catalogued under FDA product code HWC and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.