SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS

SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS is an FDA 510(k)-cleared medical device (K051879) manufactured by Synthes (Usa). 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 4, 2005. Regulation: 8.