Miach Orthopaedics, Inc.
FDA 510(k) & PMA Approved Devices — 2 products
Total Devices2
Categories1
Latest FDA decision2026-01-13
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K251214 | BEAR® (Bridge-Enhanced ACL Restoration) Implant | QNI | 2026-01-13 | View |
| 510(k) | K243578 | BEAR® (Bridge-Enhanced ACL Restoration) Implant | QNI | 2025-03-06 | View |
No matching devices.
Related Clinical Trials
NCT02292004Bridge-Enhanced ACL Repair-Safety Study (BEAR Trial)ACTIVE_NOT_RECRUITINGNCT03348995The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) RestorationACTIVE_NOT_RECRUITINGNCT05398341A Prospective Cohort Post Market Registry Evaluating Outcomes of Bridge-Enhanced ACL Restoration (BEAR®)ACTIVE_NOT_RECRUITING