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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
  No 510(k) holder with active listings identified
Current 510(k) Holder
No 510(k) holder with active listings identified
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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