FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)

FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH) is an FDA 510(k)-cleared medical device (K014072) manufactured by Disc-O-Tech Medical Technologies, Ltd.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 7, 2002. Regulation: 8.