SWISSTEK 2000(TM) CAST REMOVAL SYSTEM

SWISSTEK 2000(TM) CAST REMOVAL SYSTEM is an FDA 510(k)-cleared medical device (K932653) manufactured by Carapace, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 27, 1994. Regulation: 8.