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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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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
Docket Number 19M-4007
Notice Date 08/23/2019
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 Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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