The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Ortholoc 2 With 3di Technology Pilon Fracture Plating System.
| Device ID | K201259 |
| 510k Number | K201259 |
| Device Name: | ORTHOLOC 2 With 3Di Technology Pilon Fracture Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
| Contact | Anna Hinton |
| Correspondent | Anna Hinton Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-11 |
| Decision Date | 2021-01-08 |