The following data is part of a premarket notification filed by Medline Industires, Inc. with the FDA for Medline Unite Jones Fracture Screw System.
| Device ID | K201319 |
| 510k Number | K201319 |
| Device Name: | Medline UNITE Jones Fracture Screw System |
| Classification | Screw, Fixation, Bone |
| Applicant | Medline Industires, Inc. Three Lakes Drive Northfield, IL 60030 |
| Contact | Jennifer Mason |
| Correspondent | Jennifer Mason Medline Industires, Inc. Three Lakes Drive Northfield, IL 60030 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-18 |
| Decision Date | 2020-06-17 |