GFS II STANDARD, GFS II LARGE, GFS MIMI

GFS II STANDARD, GFS II LARGE, GFS MIMI is an FDA 510(k)-cleared medical device (K133757) manufactured by Parcus Medical, 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 February 3, 2014. Regulation: 8.