The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Quartex Occipito-cervico-thoracic Spinal System, Globus Navigation Instruments.
| Device ID | K211957 |
| 510k Number | K211957 |
| Device Name: | QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments |
| Classification | Posterior Cervical Screw System |
| Applicant | Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 |
| Contact | Jennifer Antonacci |
| Correspondent | Jennifer Antonacci Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 |
| Product Code | NKG |
| Subsequent Product Code | KWP |
| Subsequent Product Code | OLO |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-24 |
| Decision Date | 2021-08-18 |