The following data is part of a premarket notification filed by Orthopediatrics, Corp. with the FDA for Response Navigation Instruments.
| Device ID | K203573 |
| 510k Number | K203573 |
| Device Name: | RESPONSE Navigation Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| 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 | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-07 |
| Decision Date | 2021-02-04 |