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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 K042249
Device Name CLS SPOTORNO STEM
Applicant
ZIMMER AUSTIN, INC.
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Applicant Contact AUDREY SWEARINGEN
Correspondent
ZIMMER AUSTIN, INC.
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Correspondent Contact AUDREY SWEARINGEN
Regulation Number888.3353
Classification Product Code
LZO  
Date Received08/19/2004
Decision Date 09/15/2004
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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