The following data is part of a premarket notification filed by Orthopediatrics, Corp with the FDA for Orthopediatrics Cannulated Screw System.
Device ID | K190324 |
510k Number | K190324 |
Device Name: | OrthoPediatrics Cannulated Screw System |
Classification | Screw, Fixation, Bone |
Applicant | Orthopediatrics, Corp 2850 Frontier Drive Warsaw, IN 46582 |
Contact | Jen Gregory |
Correspondent | Jen Gregory Orthopediatrics, Corp 2850 Frontier Drive Warsaw, IN 46582 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-02-13 |
Decision Date | 2019-07-05 |