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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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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 st., suite 100
westborough,  MA  01581
Contact martha shadan
Regulation Number888.3044
Classification Product Code
QNI  
Date Received06/04/2020
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
Predetermined Change
Control Plan Authorized		 No
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