
Miach Orthopaedics, Inc.
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BEAR (Bridge-Enhanced ACL Repair) Implant is an FDA 510(k)-cleared medical device (DEN200035) manufactured by Miach Orthopaedics, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 15, 2020. Regulation: 8.