K243578
- 510(k) number
- K243578
- Device name
- BEAR® (Bridge-Enhanced ACL Restoration) Implant
- Applicant
- Miach Orthopaedics, Inc. MA · US
- Product code
- QNI — Resorbable Implant For Anterior Cruciate Ligament (A
- Decision date
- 2025-03-06
- Date received
- 2024-11-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K243578.pdf
Official FDA record: K243578
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.