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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.
 
DeviceSTAR PSI System
Generic NameProsthesis, ankle, uncemented, non-constrained
ApplicantDjo Global
9800 Metric Blvd.
Austin, TX 78758
PMA NumberP050050
Supplement NumberS023
Date Received04/29/2022
Decision Date11/22/2022
Product Code NTG 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for STAR PSI System, and a new manufacturing facility at Medical Modeling, a 3D Systems Company, 5381 South Alkire Circle, Littleton, CO 80127.
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