The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Assure Anterior Cervical Plate System, Providence Anterior Cervical Plate System, Vip Anterior Cervical Plate System, Xtend Anterior Cervical Plate System, Unify Dynamic Anterior Cervical Plate System, Citadel Anterior Lumbar Plate System, Truss Thor.
| Device ID | K181846 |
| 510k Number | K181846 |
| Device Name: | ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thor |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| 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 | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-11 |
| Decision Date | 2018-11-06 |
| Summary: | summary |