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FDA 510(k) Applications for Medical Device Product Code "QNI"
FDA 510(k) Number
Applicant
Device Name
Decision Date
DEN200035
Miach Orthopaedics, Inc.
BEAR (Bridge-Enhanced ACL Repair) Implant
12/16/2020
K243578
Miach Orthopaedics, Inc.
BEAR« (Bridge-Enhanced ACL Restoration) Implant
03/06/2025
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