The following data is part of a premarket notification filed by Spineex Inc. with the FDA for Spineex Sagittae® Lateral Lumbar Interbody Fusion Devices.
| Device ID | K190193 |
| 510k Number | K190193 |
| Device Name: | SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SpineEX Inc. 4046 Clipper Court Fremont, CA 94538 |
| Contact | Andrew Rogers |
| Correspondent | Meredith Lee May Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-04 |
| Decision Date | 2019-03-04 |
| Summary: | summary |