BIOMECHANIC LOW-PROFILE CABLE SYSTEM

BIOMECHANIC LOW-PROFILE CABLE SYSTEM is an FDA 510(k)-cleared medical device (K951844) manufactured by Biomechanic, 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 July 12, 1995. Regulation: 8.