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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 (TTR) Implant
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 NumberS002
Date Received01/17/2024
Decision Date02/08/2024
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 
Modifications to the inspection dimension b on the subject device, which changes the plane in which the mediolateral dimension is taken, and visual inspection to a calibrated polishing block for inspection of the light polished non-articulating areas.
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