
Osteonics Corp.
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OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR is an FDA 510(k)-cleared medical device (K923616) 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 October 29, 1992. Regulation: 8.