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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K954543
Device Name GO UNIVERSALK-WIRE FLUTED DRILL
Applicant
Genesis Orthopedics, Inc.
169 Bent St.
Cambridge,  MA  02141
Applicant Contact DOUGLAS FOGG
Correspondent
Genesis Orthopedics, Inc.
169 Bent St.
Cambridge,  MA  02141
Correspondent Contact DOUGLAS FOGG
Regulation Number888.3040
Classification Product Code
HTY  
Subsequent Product Code
HTW  
Date Received09/28/1995
Decision Date 12/08/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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