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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K862311
Device Name SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PIN
Applicant
Warsaw Orthopedic, Inc.
P.O. Box 1157
Warsaw,  IN  46580
Applicant Contact JAMES RITTER
Correspondent
Warsaw Orthopedic, Inc.
P.O. Box 1157
Warsaw,  IN  46580
Correspondent Contact JAMES RITTER
Regulation Number888.3030
Classification Product Code
KTT  
Date Received06/17/1986
Decision Date 07/25/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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