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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received03/17/2017
Decision Date08/23/2019
Product Code
QGP[ Registered Establishments with QGP ]
Docket Number 19M-4007
Notice Date 08/19/2019
Advisory Committee Orthopedic
Clinical Trials NCT02200302
NCT03071445
NCT03071471
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the minimally invasive deformity correction (mid-c) system. This device 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 45 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 to t12.
Approval OrderApproval Order
SummarySummary of Safety And Probable Benefit
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 
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