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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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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 HDE to get an up-to-date view of this device.
 
Trade Namerestor3d Total Talus Replacement
Classification Nameprosthesis, total talus replacement, metal
Generic Nameprosthesis, total talus replacement, metal
Applicant
restor3d, Inc.
311 w. corporation street
durham, NC 27701
HDE NumberH230003
Supplement NumberS004
Date Received02/14/2024
Decision Date03/14/2024
Product Code
QNN[ Registered Establishments with QNN ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
An additional supplier for nitric acid during the manufacturing of the restor3d total talus replacement implant.
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