H-H HUNTER ACTIVE TENDON IMPLANT BC

H-H HUNTER ACTIVE TENDON IMPLANT BC is an FDA 510(k)-cleared medical device (K872293) manufactured by Holter-Hausner Intl.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 27, 1987. Regulation: 8.