Panels › Orthopedic › Product code QNI · Class 2
Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair
Regulation 888.3044
1510(k)s in 12 months (3 all time)
2recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in QNI
| Company | 510(k)s | Recalls |
|---|---|---|
| Miach Orthopaedics, Inc. | 3 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 29, 2026 | Miach Orthopaedics BEAR Implant. Model Number: 1000. Open, Classified |
QNI | K243578 |
| Nov 7, 2025 | Miach Orthopaedics BEAR Implant (Bridge-Enhanced ACL Restoration);
Model/Catalog: 1000; Open, Classified |
QNI | K243578 |
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