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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 (STAR Ankle)
Generic NameProsthesis, ankle, uncemented, non-constrained
ApplicantDjo Global
9800 Metric Blvd.
Austin, TX 78758
PMA NumberP050050
Supplement NumberS018
Date Received03/24/2021
Decision Date04/19/2021
Product Code NTG 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Due to the breakage of the original grinding machine, the old grinding machine is no longer able to function and therefore needs to be replaced.
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