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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 NumberS002
Date Received09/12/2019
Decision Date10/24/2019
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 
Approval for design changes including the addition of a stopper pin in the device base, modification of the locking tooth and locking nut, additional sizes of pedicle screws, and increased extension length of the mid-c 125 mm device. New components include low profile pedicle screws and associated instruments. Labeling was updated to reflect the new components.
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