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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 NumberS008
Date Received04/15/2026
Decision Date05/11/2026
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 
A new material supplier to be implemented for the total talus replacement (ttr) implant at the restor3d durham, nc facility.
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