Stablyx CMC Arthroplasty Implant System

Stablyx CMC Arthroplasty Implant System is an FDA 510(k)-cleared medical device (K180744) 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 April 10, 2018. Regulation: 8.