BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM

BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM is an FDA 510(k)-cleared medical device (K992058) manufactured by Biomet, 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 June 30, 1999. Regulation: 8.