The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Ellipse And Protex Ct Occipito-cervico-thoracic Spinal Systems.
| Device ID | K150552 |
| 510k Number | K150552 |
| Device Name: | ELLIPSE And PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS |
| Classification | Posterior Cervical Screw System |
| Applicant | GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
| Contact | Kelly J. Baker |
| Correspondent | Kelly J. Baker GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
| Product Code | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-04 |
| Decision Date | 2015-06-04 |
| Summary: | summary |