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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 uncemented acetabular component)
510(k) Number K110836
Device Name CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY
Applicant
ZIMMER GMBH
P.O. BOX 708
warsaw,  IN  46581 -0708
Applicant Contact daniel j williman
Correspondent
ZIMMER GMBH
P.O. BOX 708
warsaw,  IN  46581 -0708
Correspondent Contact daniel j williman
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDI   JDL   KWZ   LPH   LWJ  
LZO  
Date Received03/25/2011
Decision Date 10/07/2011
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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