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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 NumberS009
Date Received04/22/2020
Decision Date07/02/2020
Product Code
QGP[ Registered Establishments with QGP ]
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for expansion of the indications for use to be: “the mid-c system is indicated for use in patients with adolescent idiopathic scoliosis (ais) for treatment of single curves classified as lenke 1 (thoracic major curve) or lenke 5 (thoracolumbar/lumbar major curve), having a cobb angle of 35 to 60 degrees which reduces to less than or equal to 30 degrees on lateral side-bending radiographs, and thoracic kyphosis less than 55 degrees as measured from t5-t12. Use of the mid-c system in patients with curves of lower magnitudes (i. E. , less than 40 degrees) is based on the risk for curve progression. ” labeling was updated to reflect the revised indications for use.
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