SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM

SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM is an FDA 510(k)-cleared medical device (K043310) manufactured by Synthes (Usa). This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 4, 2005. Regulation: 8.