
Kapp Surgical Instrument, Inc.
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MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005 is an FDA 510(k)-cleared medical device (K050655) 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 7, 2005. Regulation: 8.