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 | K200816 |
| 510k Number | K200816 |
| 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 | Nathan Wright 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 | 2020-03-30 |
| Decision Date | 2020-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00819837021245 | K200816 | 000 |
| 00819837020361 | K200816 | 000 |
| 00819837020804 | K200816 | 000 |
| 00819837020828 | K200816 | 000 |
| 00819837020842 | K200816 | 000 |
| 00819837020866 | K200816 | 000 |
| 00819837020880 | K200816 | 000 |
| 00819837021023 | K200816 | 000 |
| 00819837021047 | K200816 | 000 |
| 00819837021061 | K200816 | 000 |
| 00819837021085 | K200816 | 000 |
| 00819837021108 | K200816 | 000 |
| 00819837021122 | K200816 | 000 |
| 00819837021207 | K200816 | 000 |
| 00819837021221 | K200816 | 000 |
| 00819837020309 | K200816 | 000 |