BDH UNIVERSAL HIP SYSTEM SURGEON

BDH UNIVERSAL HIP SYSTEM SURGEON is an FDA 510(k)-cleared medical device (K833468) manufactured by Carbomedics, 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 December 26, 1983. Regulation: 8.