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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 |
|
HDE Number | H170001 |
Supplement Number | S002 |
Date Received | 09/12/2019 |
Decision Date | 10/24/2019 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
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. |