OSTEONICS(R) MID-SHAFT CEMENT SPACER

OSTEONICS(R) MID-SHAFT CEMENT SPACER is an FDA 510(k)-cleared medical device (K910461) manufactured by Osteonics Corp.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 7, 1991. Regulation: 8.