
Amedica Corp.
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MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004 is an FDA 510(k)-cleared medical device (K050699) manufactured by Amedica 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 14, 2005. Regulation: 8.