Device Classification Name |
resorbable implant for anterior cruciate ligament (acl) repair
|
De Novo Number |
DEN200035 |
Device Name |
BEAR (Bridge-Enhanced ACL Repair) Implant |
Requester |
miach orthopaedics, inc. |
69 milk street |
suite 100 |
westborough,
MA
01581
|
|
Contact |
martha shadan |
|
Regulation Number | 888.3044
|
Classification Product Code |
|
Date Received | 06/04/2020 |
Decision Date | 12/16/2020 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Orthopedic
|
Review Advisory Committee |
Orthopedic
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|