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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K063577
Device Name FEMORAL INTRAFIX SCREW AND SHEATH
Applicant
Johnson & Johnson Company
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact Ruth Forstadt
Correspondent
Johnson & Johnson Company
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact Ruth Forstadt
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HWC  
Date Received11/30/2006
Decision Date 01/25/2007
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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