The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Fortify And Fortify Integrated Corpectomy Spacers, Xpand Corpectomy Spacers, Niko Corpectomy Spacers, Sustain Spacers, Coalition Spacers, Patriot Lumbar Spacers, Patriot Cervical Spacers, Altera Spacers, Rise Spacers, Caliber Spacers, Elsa Spacers, L.
| Device ID | K171848 |
| 510k Number | K171848 |
| Device Name: | FORTIFY And FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, L |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 |
| Contact | Lori Burns |
| Correspondent | Lori Burns Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 |
| Product Code | MAX |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MQP |
| Subsequent Product Code | ODP |
| Subsequent Product Code | OVD |
| Subsequent Product Code | OVE |
| Subsequent Product Code | PLR |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-21 |
| Decision Date | 2017-12-21 |
| Summary: | summary |