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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 NumberS001
Date Received04/19/2021
Decision Date12/10/2021
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 the ti6al4v with tin coating version of the patient specific talus spacer, and new manufacturing facilities at fit production gmbh, am grohberg 1, 92331 lupburg, germany, and dot america, inc. , 335 towerview drive, columbia city, in 46725.
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