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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameOSTEO CERAMIC HIP
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Generic Nameno product code
ApplicantRICHARDS MEDICAL CO., INC.
PMA NumberP810048
Supplement NumberS012
Date Received11/28/1986
Decision Date05/10/1988
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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