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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 NumberS003
Date Received11/21/2022
Decision Date12/19/2022
Product Code
QNN[ Registered Establishments with QNN ]
Advisory Committee Orthopedic
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.
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