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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 NameREFLECTION CERAMIC ACETABULAR HIP (RCHS) SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Generic Nametotal hip arthroplasty system
ApplicantSMITH & NEPHEW, INC.
PMA NumberP030022
Supplement NumberS013
Date Received08/12/2009
Decision Date09/11/2009
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
New raw material supplier manufacturing site that will be used to forge the anthology hip stems associated with the device.
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