The following data is part of a premarket notification filed by Globus Medical, Inc. with the FDA for Zyfuse Facet Fixation System.
| Device ID | K090952 |
| 510k Number | K090952 |
| Device Name: | ZYFUSE FACET FIXATION SYSTEM |
| Classification | System, Facet Screw Spinal Device |
| Applicant | GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER Audubon, PA 19403 |
| Contact | Kelly J Baker |
| Correspondent | Kelly J Baker GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER Audubon, PA 19403 |
| Product Code | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-03 |
| Decision Date | 2009-07-14 |
| Summary: | summary |