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 |