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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
510(k) Number K071856
Device Name ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S) 7848 SERIES( MODULAR NECKS), 7713 SERIES
Applicant
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46581
Applicant Contact DALENE BINKLEY
Correspondent
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46581
Correspondent Contact DALENE BINKLEY
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDL   LPH   LWJ   MEH  
Date Received07/05/2007
Decision Date 07/30/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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