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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 K954555
Device Name VERSA-FX FEMORAL FIXATION SYSTEM
Applicant
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46581 -0708
Applicant Contact LYNNETTE WHITAKER
Correspondent
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46581 -0708
Correspondent Contact LYNNETTE WHITAKER
Regulation Number888.3030
Classification Product Code
KTT  
Date Received10/02/1995
Decision Date 01/26/1996
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
Recalls CDRH Recalls
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