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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