
Std Mfg., Inc.
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CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM is an FDA 510(k)-cleared medical device (K023096) manufactured by Std Mfg., Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 9, 2003. Regulation: 8.