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 |