SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System
Spinous Process Plate
Globus Medical Inc.
The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Sp-fix® Spinous Process Fixation Plate, Relieve® Laminoplasty Fixation System.
Pre-market Notification Details
| Device ID | K180156 |
| 510k Number | K180156 |
| Device Name: | SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System |
| Classification | Spinous Process Plate |
| Applicant | Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 |
| Contact | Lori Burns |
| Correspondent | Lori Burns Globus Medical Inc. 2560 General Armistead Avenue Audubon, PA 19403 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-19 |
| Decision Date | 2018-03-07 |
| Summary: | summary |
Trademark Results [SP-Fix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SP-FIX 85051909 4094316 Live/Registered |
Globus Medical, Inc. 2010-06-01 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.