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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 | S007 |
Date Received | 02/11/2020 |
Decision Date | 02/14/2020 |
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 modifications to the pedicle screw holder and distractor instruments, new extender angle measurement tool and low profile nut leader holder instruments, and addition of gravity-displacement steam sterilization parameters for non-sterile provided components. |