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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair
510(k) Number K243578
Device Name BEAR® (Bridge-Enhanced ACL Restoration) Implant
Applicant
Miach Orthopaedics, Inc.
69 Milk St., Suite 100
Westborough,  MA  01581
Applicant Contact Rita Paparazzo
Correspondent
Broderick Regulatory Consulting, LLC
7 Kendall St.
Winchester,  MA  01890
Correspondent Contact Julie Broderick
Regulation Number888.3044
Classification Product Code
QNI  
Date Received11/19/2024
Decision Date 03/06/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Clinical Trials NCT03348995
NCT05398341
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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