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 | K181531 |
| 510k Number | K181531 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-11 |
| Decision Date | 2018-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00819837020071 | K181531 | 000 |
| 00819837020019 | K181531 | 000 |
| 00819837020446 | K181531 | 000 |
| 00819837020224 | K181531 | 000 |
| 00819837020217 | K181531 | 000 |
| 00819837020200 | K181531 | 000 |
| 00819837020194 | K181531 | 000 |
| 00819837020101 | K181531 | 000 |
| 00819837020095 | K181531 | 000 |
| 00819837020088 | K181531 | 000 |
| 00819837020064 | K181531 | 000 |
| 00819837021320 | K181531 | 000 |
| 00819837020026 | K181531 | 000 |
| 00819837020033 | K181531 | 000 |
| 00819837020040 | K181531 | 000 |
| 00819837020989 | K181531 | 000 |
| 00819837020965 | K181531 | 000 |
| 00819837020934 | K181531 | 000 |
| 00819837020927 | K181531 | 000 |
| 00819837020903 | K181531 | 000 |
| 00819837020743 | K181531 | 000 |
| 00819837020705 | K181531 | 000 |
| 00819837020668 | K181531 | 000 |
| 00819837020620 | K181531 | 000 |
| 00819837020583 | K181531 | 000 |
| 00819837020057 | K181531 | 000 |
| 00819837021283 | K181531 | 000 |