The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Crossway Spinal Access System.
| Device ID | K190598 |
| 510k Number | K190598 |
| Device Name: | CROSSWAY Spinal Access System |
| Classification | Arthroscope |
| 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 | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-07 |
| Decision Date | 2019-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889095998696 | K190598 | 000 |
| 00889095998689 | K190598 | 000 |
| 00889095998634 | K190598 | 000 |
| 00889095741025 | K190598 | 000 |
| 00889095740981 | K190598 | 000 |
| 00889095998672 | K190598 | 000 |
| 00889095998658 | K190598 | 000 |
| 00889095998641 | K190598 | 000 |
| 00889095998665 | K190598 | 000 |