PRIME MODULAR ENDO HEAD

PRIME MODULAR ENDO HEAD is an FDA 510(k)-cleared medical device (K962646) manufactured by Orthopaedic Innovations, 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 September 22, 1996. Regulation: 8.