510(k) K251214 · QNI Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair
BEAR® (Bridge-Enhanced ACL Restoration) Implant
| Applicant | Miach Orthopaedics, Inc., Westborough MA, US |
| Decision | Substantially Equivalent, Jan 13, 2026 |
| Received | Apr 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251214
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.