
Shoulder Options, Inc.
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ICUFF REPAIR PLATE, RIGHT; CUFF REPAIR PLATE. LEFT; ANCHOR BOLT, 10MM THROUGH 50MM is an FDA 510(k)-cleared medical device (K102539) manufactured by Shoulder Options, 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 February 23, 2011. Regulation: 8.