Clearance Summary
BEAR® (Bridge-Enhanced ACL Restoration) Implant received FDA 510(k) clearance under submission number K243578, sponsored by Miach Orthopaedics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2025-03-06.
- Submission: K243578
- Applicant / Sponsor: Miach Orthopaedics, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3044
- Decision date: 2025-03-06
Classification & Regulation
This clearance is catalogued under FDA product code QNI and 21 CFR 888.3044, within the Orthopedic review panel as a Class II device.