|
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 | S001 |
Date Received | 08/30/2019 |
Decision Date | 10/23/2019 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
Supplement Reason | postapproval study protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for h170001. |