The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Unite® Snap-off Screws.
| Device ID | K170782 |
| 510k Number | K170782 |
| Device Name: | Medline UNITE® Snap-Off Screws |
| Classification | Screw, Fixation, Bone |
| Applicant | Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Contact | Jennifer Mason |
| Correspondent | Jennifer Mason Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-15 |
| Decision Date | 2017-08-18 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MEDLINE UNITE 85921082 4653673 Live/Registered |
Medline Industries, Inc. 2013-05-02 |