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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 st.
misgav business park 20174
HDE NumberH170001
Supplement NumberS006
Date Received01/10/2020
Decision Date02/12/2020
Product Code
QGP[ Registered Establishments with QGP ]
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) protocol.
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