The following data is part of a premarket notification filed by Globus Medical, Inc. with the FDA for Gateway Thoracolumbar Plate System.
| Device ID | K062407 |
| 510k Number | K062407 |
| Device Name: | GATEWAY THORACOLUMBAR PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | GLOBUS MEDICAL, INC. 303 SCHELL LANE Phoenixville, PA 19460 |
| Contact | Kelly J Baker |
| Correspondent | Kelly J Baker GLOBUS MEDICAL, INC. 303 SCHELL LANE Phoenixville, PA 19460 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-17 |
| Decision Date | 2006-09-06 |
| Summary: | summary |