The following data is part of a premarket notification filed by Orthopediatrics, Inc. with the FDA for Orthopediatrics Wrist Fusion Plate.
| Device ID | K172425 |
| 510k Number | K172425 |
| Device Name: | OrthoPediatrics Wrist Fusion Plate |
| Classification | Plate, Fixation, Bone |
| Applicant | OrthoPediatrics, Inc. 2850 Frontier Drive Warsaw, IN 46582 |
| Contact | Adam Cargill |
| Correspondent | Adam Cargill OrthoPediatrics, Inc. 2850 Frontier Drive Warsaw, IN 46582 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-10 |
| Decision Date | 2017-12-06 |
| Summary: | summary |