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 |