K251214
- 510(k) number
- K251214
- 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
- 2026-01-13
- Date received
- 2025-04-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251214.pdf
Official FDA record: K251214
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.