SMARTMIX PRE-FILLED MIXING SYSTEM

SMARTMIX PRE-FILLED MIXING SYSTEM is an FDA 510(k)-cleared medical device (K042591) manufactured by DePuy Orthopaedics, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 21, 2004. Regulation: 8.