ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM

ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM is an FDA 510(k)-cleared medical device (K935593) manufactured by Biodynamic Technologies, 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 October 13, 1994. Regulation: 8.