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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 K043356
Device Name WAGNER SL REVISION STEM LATERAL
Applicant
ZIMMER AUSTIN, INC.
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Applicant Contact AUDREY SWEARINGTON
Correspondent
ZIMMER AUSTIN, INC.
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Correspondent Contact AUDREY SWEARINGTON
Regulation Number888.3353
Classification Product Code
LZO  
Date Received12/06/2004
Decision Date 04/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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