
Skeletal Dynamics, LLC
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STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5 is an FDA 510(k)-cleared medical device (K111068) manufactured by Skeletal Dynamics, LLC. 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 29, 2011. Regulation: 8.