BEAR (Bridge-Enhanced ACL Repair) Implant
FDA 510(k) clearance DEN200035 · decided 2020-12-16
Clearance details
- K-number
- DEN200035
- Device name
- BEAR (Bridge-Enhanced ACL Repair) Implant
- Applicant
- Miach Orthopaedics, Inc.
- Decision
- Unknown
- Date received
- 2020-06-04
- Decision date
- 2020-12-16
- Days to decision
- 195 days
- Clearance type
- Direct
- Product code
- QNI
- Device class
- 2
- Regulation number
- 888.3044
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Westborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BEAR® (Bridge-Enhanced ACL Restoration) Implant (K251214) | Miach Orthopaedics, Inc. | 2026-01-13 |
| BEAR® (Bridge-Enhanced ACL Restoration) Implant (K243578) | Miach Orthopaedics, Inc. | 2025-03-06 |
Recalls involving this device
No recalls on record reference this clearance.