The following data is part of a premarket notification filed by Orthopediatrics Corp. with the FDA for Drive Rail System.
| Device ID | K220809 |
| 510k Number | K220809 |
| Device Name: | Drive Rail System |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | OrthoPediatrics Corp. 2850 Frontier Drive Warsaw, IN 46582 |
| Contact | Yan Li |
| Correspondent | Yan Li OrthoPediatrics Corp. 2850 Frontier Drive Warsaw, IN 46582 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-21 |
| Decision Date | 2022-04-08 |