Medline UNITE® Digital Fusion Screw System
Screw, Fixation, Bone
Medline Industries, Inc.
The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Unite® Digital Fusion Screw System.
Pre-market Notification Details
| Device ID | K211944 |
| 510k Number | K211944 |
| Device Name: | Medline UNITE® Digital Fusion Screw System |
| Classification | Screw, Fixation, Bone |
| Applicant | Medline Industries, Inc. Three L Akes Drive Northfield, IL 60093 |
| Contact | Jennifer Mason |
| Correspondent | Jennifer Mason Medline Industries, Inc. Three L Akes 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 | 2021-06-23 |
| Decision Date | 2021-07-22 |
Trademark Results [Medline UNITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MEDLINE UNITE 85921082 4653673 Live/Registered |
Medline Industries, Inc. 2013-05-02 |
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