Clearance Summary
SINEFIX received FDA 510(k) clearance under submission number K254176, sponsored by BAAT Medical Products B.V.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2026-03-16.
- Submission: K254176
- Applicant / Sponsor: BAAT Medical Products B.V.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2026-03-16
Classification & Regulation
This clearance is catalogued under FDA product code MBI and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.