
Kapp Surgical Instrument, Inc.
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KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT is an FDA 510(k)-cleared medical device (K030237) manufactured by Kapp Surgical Instrument, 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 August 28, 2003. Regulation: 8.