NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM

NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM is an FDA 510(k)-cleared medical device (K945516) manufactured by Intermedics Orthopedics. 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 13, 1995. Regulation: 8.