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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R. ANKLE)
Generic NameProsthesis, ankle, uncemented, non-constrained
ApplicantDJO Global
9800 Metric Boulevard
Austin, TX 78758
PMA NumberP050050
Supplement NumberS010
Date Received07/12/2016
Decision Date09/28/2016
Product Code NTG 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the use of three specific saw blades in the S.T.A.R. ankle surgical technique.
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