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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K954511
Device Name GO INTRAMEDULLARY NAIL LOCKING SCREW
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
HWC  
Date Received09/28/1995
Decision Date 12/19/1995
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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