Clearance Summary
Synchfix EVT received FDA 510(k) clearance under submission number K251643, sponsored by Wright Medical Technology, Inc. (Stryker Corporation). The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2025-10-29.
- Submission: K251643
- Applicant / Sponsor: Wright Medical Technology, Inc. (Stryker Corporation)
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2025-10-29
Classification & Regulation
This clearance is catalogued under FDA product code HTN and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.