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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 NameSCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM STAR ANKLE
Classification Nameprosthesis, ankle, uncemented, non-constrained
ApplicantSMALL BONE INNOVATIONS, INC.
PMA NumberP050050
Supplement NumberS006
Date Received03/10/2014
Decision Date06/04/2014
Product Code
NTG[ Registered Establishments with NTG ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changing the inner pouch material for the star sliding core component.
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