510(k) K243578 · 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, Mar 6, 2025 |
| Received | Nov 19, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243578
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 29, 2026 | Miach Orthopaedics BEAR Implant. Model Number: 1000. Open, Classified |
QNI | None listed |
| Nov 7, 2025 | Miach Orthopaedics BEAR Implant (Bridge-Enhanced ACL Restoration);
Model/Catalog: 1000; Open, Classified |
QNI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.