Company · US
Miach Orthopaedics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2020 to 2026. Name variants (Inc, Corp, punctuation) are merged.
3510(k) clearances (1 in 12 months)
2recalls (1 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| QNI | Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair | 5 |
Latest 510(k) clearances
| 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 |
Latest recalls
| 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 |