
Surgitech, Inc.
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SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 is an FDA 510(k)-cleared medical device (K031576) manufactured by Surgitech, Inc.. This device is classified under the Physical Medicine specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 30, 2003. Regulation: 8.