510(k) K050655

MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005 by Kapp Surgical Instrument, Inc. — Product Code HRS

K050655 is an FDA 510(k) premarket notification submitted by Kapp Surgical Instrument, Inc. for the device "MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005". The FDA issued a decision of Substantially Equivalent on August 8, 2005. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Kapp Surgical Instrument, Inc. has at least 8 other 510(k) clearances on record.