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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 NameMinimally Invasive Deformity Correction (MID-C) System
Classification Nameposterior ratcheting rod system
Generic Nameposterior ratcheting rod system
Applicant
ApiFix, Ltd.
17 thelet street
misgav business park 20174
HDE NumberH170001
Supplement NumberS013
Date Received04/22/2021
Decision Date06/21/2021
Product Code
QGP[ Registered Establishments with QGP ]
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Minor design modifications to improve device manufacturability and improve device strength, minor modifications to instrumentation, and the addition of an instrument.
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