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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 NumberS006
Date Received05/17/2024
Decision Date06/11/2024
Product Code
QNN[ Registered Establishments with QNN ]
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for a manufacturing site change from the original paragon 28 new jersey location to the paragon 28 colorado location at 14445 grasslands dr. , englewood, co 80112, to perform device inspection, label printing and packaging, and to use the paragon 28 colorado quality management system (qms) for the patient specific talus spacer.
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