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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 st.
durham, NC 27701
HDE NumberH230003
Supplement NumberS006
Date Received09/19/2025
Decision Date10/14/2025
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 
Process change to introduce a new electric discharge machine step for total talar replacement implants manufactured at the restor3d durham, nc facility.
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