COBREX HIP STEM, MODEL 01-128-XXXXX

COBREX HIP STEM, MODEL 01-128-XXXXX is an FDA 510(k)-cleared medical device (K991869) manufactured by Implex Corp.. 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 13, 1999. Regulation: 8.