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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceOSTEO CERAMIC HIP
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantSmith & Nephew, Inc.
1450 BROOKS RD.
MEMPHIS, TN 38116
PMA NumberP810048
Date Received10/06/1981
Decision Date11/05/1982
Withdrawal Date 09/24/2007
Product Code MRA 
Docket Number 81M-0373
Notice Date 12/10/1982
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
Supplements:  S001 S003 S006 S007 S008 S009 S010 S011 S012 
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