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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K050655
Device Name MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005
Applicant
Kapp Surgical Instrument, Inc.
4919 Warrensville Center Rd.
Warrensville,  OH  44128
Applicant Contact ALBERT SANTILLI
Correspondent
Kapp Surgical Instrument, Inc.
4919 Warrensville Center Rd.
Warrensville,  OH  44128
Correspondent Contact ALBERT SANTILLI
Regulation Number888.3030
Classification Product Code
HRS  
Date Received03/14/2005
Decision Date 08/08/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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