The following data is part of a premarket notification filed by Medline Industries, Lp with the FDA for Medline Unite Calcaneal Fracture Plating System.
| Device ID | K213567 |
| 510k Number | K213567 |
| Device Name: | Medline UNITE Calcaneal Fracture Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | Medline Industries, LP Three Lakes Drive Northfield, IL 60093 |
| Contact | Jennifer Mason |
| Correspondent | Jennifer Mason Medline Industries, LP Three Lakes Drive Northfield, IL 60093 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-09 |
| Decision Date | 2022-03-02 |