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 |