SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS

SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS is an FDA 510(k)-cleared medical device (K041533) manufactured by Synthes (Usa). This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 31, 2004. Regulation: 8.