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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 NumberS005
Date Received03/01/2024
Decision Date03/27/2024
Product Code
QNN[ Registered Establishments with QNN ]
Advisory Committee Orthopedic
Clinical Trials NCT06311331
Supplement Typenormal 75 day track
Supplement Reason postapproval study protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval of the revised protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for h230003(restor3d total talus replacement).
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