The following data is part of a De Novo classification by Miach Orthopaedics, Inc. with the FDA for Bear (bridge-enhanced Acl Repair) Implant.
| DeNovo ID | DEN200035 |
| Device Name: | BEAR (Bridge-Enhanced ACL Repair) Implant |
| Classification | Resorbable Implant For Anterior Cruciate Ligament (acl) Repair |
| Applicant | Miach Orthopaedics, Inc. 69 Milk Street suite 100 Westborough, MA 01581 |
| Contact | Martha Shadan |
| Product Code | QNI |
| CFR Regulation Number | 888.3044 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Orthopedic |
| Classification Advisory | Orthopedic |
| Type | Direct |
| Date Received | 2020-06-04 |
| Decision Date | 2020-12-16 |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860002987804 | DEN200035 | 000 |