The following data is part of a premarket notification filed by Orthopediatrics, Corp. with the FDA for Orthopediatrics Locking Proximal Femur System Cortical Screws.
| Device ID | K162307 |
| 510k Number | K162307 |
| Device Name: | OrthoPediatrics Locking Proximal Femur System Cortical Screws |
| Classification | Plate, Fixation, Bone |
| Applicant | ORTHOPEDIATRICS, CORP. 2850 FRONTIER DRIVE Warsaw, IN 46582 |
| Contact | Adam Cargill |
| Correspondent | Adam Cargill ORTHOPEDIATRICS, CORP. 2850 FRONTIER DRIVE Warsaw, IN 46582 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-17 |
| Decision Date | 2016-09-27 |
| Summary: | summary |