The following data is part of a premarket notification filed by Globus Medical, Inc. with the FDA for Patriot Spacers.
| Device ID | K122097 |
| 510k Number | K122097 |
| Device Name: | PATRIOT SPACERS |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | GLOBUS MEDICAL, INC. 2560 General Armistead Ave VALLEY FORGE BUSINESS CENTER Audubon, PA 19403 |
| Contact | Meriam Youssef |
| Correspondent | Meriam Youssef GLOBUS MEDICAL, INC. 2560 General Armistead Ave VALLEY FORGE BUSINESS CENTER Audubon, PA 19403 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-16 |
| Decision Date | 2012-12-06 |
| Summary: | summary |