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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 NumberS002
Date Received07/20/2021
Decision Date01/14/2022
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 for the protocol of the post-approval study that paragon 28, inc. Agreed to conduct as part of the conditions of approval for the patient specific talus spacer (h200001 for cocr version and h200001/s001 for ti6al4v with tin coating version), approved on february 17, 2021 for h200001 and december 10, 2021 for h200001/s001.
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