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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 NamePatient Specific Talus Spacer
Classification Nameprosthesis, total talus replacement, metal
Generic Nameprosthesis, total talus replacement, metal
Applicant
Paragon 28, Inc.
14445 grasslands dr.
englewood, CO 80112
HDE NumberH200001
Supplement NumberS007
Date Received06/28/2024
Decision Date07/18/2024
Product Code
QNN[ Registered Establishments with QNN ]
Advisory Committee Orthopedic
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the addition of three (3) potential complications and adverse reactions to the device labeling.
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