OSTEONICS 22MM, +10 NECK BEARING HEADS

OSTEONICS 22MM, +10 NECK BEARING HEADS is an FDA 510(k)-cleared medical device (K933359) manufactured by Osteonics Corp.. 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 6, 1994. Regulation: 8.