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Trade Name | Minimally Invasive Deformity Correction (MID-C) System |
Classification Name | posterior ratcheting rod system |
Generic Name | posterior ratcheting rod system |
Applicant |
ApiFix, Ltd. |
17 thelet street |
misgav business park 20174 |
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HDE Number | H170001 |
Supplement Number | S009 |
Date Received | 04/22/2020 |
Decision Date | 07/02/2020 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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. |