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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 K032348
Device Name CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP
Applicant
CENTERPULSE ORTHOPEDICS, INC.
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Applicant Contact ROBERT M WOLFARTH
Correspondent
CENTERPULSE ORTHOPEDICS, INC.
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Correspondent Contact ROBERT M WOLFARTH
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
JDI   KWA   LWJ  
Date Received07/30/2003
Decision Date 10/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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