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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 13, 2026 | K251214 | BEAR® (Bridge-Enhanced ACL Restoration) Implant Miach Orthopaedics, Inc. | QNI |
| Mar 6, 2025 | K243578 | BEAR® (Bridge-Enhanced ACL Restoration) Implant Miach Orthopaedics, Inc. | QNI |
| Dec 16, 2020 | DEN200035 | BEAR (Bridge-Enhanced ACL Repair) Implant Miach Orthopaedics, Inc. | QNI |
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