BEAR (Bridge-Enhanced ACL Repair) Implant

Resorbable Implant For Anterior Cruciate Ligament (acl) Repair

Miach Orthopaedics, Inc.

The following data is part of a De Novo classification by Miach Orthopaedics, Inc. with the FDA for Bear (bridge-enhanced Acl Repair) Implant.

Pre-market Notification Details

DeNovo IDDEN200035
Device Name:BEAR (Bridge-Enhanced ACL Repair) Implant
ClassificationResorbable Implant For Anterior Cruciate Ligament (acl) Repair
Applicant Miach Orthopaedics, Inc. 69 Milk Street suite 100 Westborough,  MA  01581
ContactMartha Shadan
Product CodeQNI  
CFR Regulation Number888.3044 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice 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 BoardOrthopedic
Classification AdvisoryOrthopedic
TypeDirect
Date Received2020-06-04
Decision Date2020-12-16
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860002987804 DEN200035 000

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