The following data is part of a premarket notification filed by Atlas Spine, Inc. with the FDA for Atlas Spine Expandable Cervical Standalone Interbody System.
| Device ID | K192570 |
| 510k Number | K192570 |
| Device Name: | Atlas Spine Expandable Cervical Standalone Interbody System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | Atlas Spine, Inc. 1555 Jupiter Park Drive, Suite 1 Jupiter, FL 33458 |
| Contact | Thomas Smith |
| Correspondent | Thomas Smith Atlas Spine, Inc. 1555 Jupiter Park Drive, Suite 1 Jupiter, FL 33458 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-18 |
| Decision Date | 2020-02-28 |