The following data is part of a premarket notification filed by Orthopediatrics Corp. with the FDA for Pediflex Flexible Nail System.
| Device ID | K201838 |
| 510k Number | K201838 |
| Device Name: | PediFlex Flexible Nail System |
| Classification | Pin, Fixation, Smooth |
| 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 | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-02 |
| Decision Date | 2021-01-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840194405935 | K201838 | 000 |
| 00840194405812 | K201838 | 000 |
| 00840194405805 | K201838 | 000 |
| 00840194405799 | K201838 | 000 |
| 00840194405782 | K201838 | 000 |
| 00840194405775 | K201838 | 000 |
| 00840194405768 | K201838 | 000 |
| 00840194405751 | K201838 | 000 |
| 00840194405744 | K201838 | 000 |
| 00840194405829 | K201838 | 000 |
| 00840194405836 | K201838 | 000 |
| 00840194405843 | K201838 | 000 |
| 00840194405928 | K201838 | 000 |
| 00840194405911 | K201838 | 000 |
| 00840194405904 | K201838 | 000 |
| 00840194405898 | K201838 | 000 |
| 00840194405881 | K201838 | 000 |
| 00840194405874 | K201838 | 000 |
| 00840194405867 | K201838 | 000 |
| 00840194405850 | K201838 | 000 |
| 00840194405737 | K201838 | 000 |