FDA Product Code
FDA Product Code QNI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3044
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251214 | BEAR® (Bridge-Enhanced ACL Restoration) Implant | Miach Orthopaedics, Inc. | 2026-01-13 | Traditional | PDF ↗ |
| K243578 | BEAR® (Bridge-Enhanced ACL Restoration) Implant | Miach Orthopaedics, Inc. | 2025-03-06 | Traditional | PDF ↗ |
| DEN200035 | BEAR (Bridge-Enhanced ACL Repair) Implant | Miach Orthopaedics, Inc. | 2020-12-16 | Direct | — |
Product code QNI · Class II · Orthopedic. Data: openFDA.