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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 K123392
Device Name AVENIR MULLER STEM
Applicant
ZIMMER GMBH
P.O. BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact KAREN O'LEARY
Correspondent
ZIMMER GMBH
P.O. BOX 708
WARSAW,  IN  46581 -0708
Correspondent Contact KAREN O'LEARY
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
KWY   KWZ   LWJ   MEH  
Date Received11/02/2012
Decision Date 03/04/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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