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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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K073567
Device Name BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES
Applicant
Zimmer GmbH
P.O. Box 708
Warsaw,  IN  46581 -0708
Applicant Contact PATRICIA JENKS
Correspondent
Zimmer GmbH
P.O. Box 708
Warsaw,  IN  46581 -0708
Correspondent Contact PATRICIA JENKS
Regulation Number888.3353
Classification Product Code
LZO  
Date Received12/20/2007
Decision Date 03/13/2008
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
Recalls CDRH Recalls
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