The following data is part of a premarket notification filed by Atlas Spine, Inc. with the FDA for Atlas Spine Expandable Interbody System.
| Device ID | K162918 |
| 510k Number | K162918 |
| Device Name: | Atlas Spine Expandable Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Atlas Spine, Inc. 1555 Jupiter Park Drive, Suite 1 Jupiter, FL 33458 |
| Contact | Thomas Smith |
| Correspondent | Meredith May Empirical Consulting, LLC. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-18 |
| Decision Date | 2017-02-09 |
| Summary: | summary |