Stable-L Lumbar Interbody System
Nexus Spine, LLC
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011390763 | 3011390763 | NEXUS SPINE, L.L.C. | 1 | N | 2026-01-01 | 2825 E COTTONWOOD PKWY STE 330 Salt Lake City UT US 84121 |
| 3018210489 | 3018210489 | NEXUS SPINE, LLC. | 1 | N | 2026-01-01 | 13867 South Bangerter Parkway, Suite 150 Draper UT US 84020 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 316348 | 1542726134 | K253331 | PressON Spinal Fixation System | NKB | 2025-10-14 |
| 179161 | 1542726134 | K253331 | PressON Spinal Fixation System | NKB | 2025-10-14 |
| 316348 | 1506456307 | K243934 | Stable-L Lumbar Interbody System | OVD | 2025-04-30 |
| 179161 | 1506456307 | K243934 | Stable-L Lumbar Interbody System | OVD | 2025-04-30 |
| 316348 | 1078356315 | K241467 | Stable-C Interbody System | OVE | 2024-07-17 |
| 179161 | 1078356315 | K241467 | Stable-C Interbody System | OVE | 2024-07-17 |
| 316348 | 1673818776 | K240416 | Tranquil-C Interbody System | ODP | 2024-03-12 |
| 179161 | 1673818776 | K240416 | Tranquil-C Interbody System | ODP | 2024-03-12 |
| 316348 | 1655941046 | K233375 | Tranquil-L Interbody System | MAX | 2024-03-20 |
| 179161 | 1655941046 | K233375 | Tranquil-L Interbody System | MAX | 2024-03-20 |
| 316348 | 1053582735 | K233234 | PressON Spinal Fixation System | NKB | 2023-10-26 |
| 179161 | 1053582735 | K233234 | PressON Spinal Fixation System | NKB | 2023-10-26 |
| 179161 | 1613683214 | K232530 | Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System | OVD | 2023-09-18 |
| 316348 | 1613683214 | K232530 | Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System | OVD | 2023-09-18 |
| 316348 | 1047779472 | K231763 | Stable-C Interbody System | OVE | 2023-08-21 |
| 179161 | 1047779472 | K231763 | Stable-C Interbody System | OVE | 2023-08-21 |
| 316348 | 1653466695 | K231486 | Stable-L Standalone Lumbar Interbody System | OVD | 2023-10-12 |
| 179161 | 1653466695 | K231486 | Stable-L Standalone Lumbar Interbody System | OVD | 2023-10-12 |
| 316348 | 1944928497 | K223627 | PreView-III™ Anterior Cervical Plate System | KWQ | 2023-02-02 |
| 179161 | 1944928497 | K223627 | PreView-III™ Anterior Cervical Plate System | KWQ | 2023-02-02 |
| 316348 | 2037584597 | K223529 | PressON Spinal Fixation System | NKB | 2023-05-02 |
| 179161 | 2037584597 | K223529 | PressON Spinal Fixation System | NKB | 2023-05-02 |
| 179161 | 1744641544 | K212498 | Stable-L Standalone Lumbar Interbody System | OVD | 2022-03-18 |
| 316348 | 1744641544 | K212498 | Stable-L Standalone Lumbar Interbody System | OVD | 2022-03-18 |
| 316348 | 1407256907 | K181702 | Tranquil-L Interbody System | MAX | 2018-09-21 |
| 179161 | 1407256907 | K181702 | Tranquil-L Interbody System | MAX | 2018-09-21 |
| 179161 | 1778739749 | K181621 | Stable-C Interbody System | OVE | 2018-10-19 |
| 316348 | 1778739749 | K181621 | Stable-C Interbody System | OVE | 2018-10-19 |
| 179161 | 1516229094 | K181483 | Tranquil Interbody System | MAX | 2018-08-27 |
| 316348 | 1516229094 | K181483 | Tranquil Interbody System | MAX | 2018-08-27 |
| 179161 | 1347564169 | K170297 | Tranquil Interbody System | MAX | 2017-06-27 |
| 316348 | 1347564169 | K170297 | Tranquil Interbody System | MAX | 2017-06-27 |
| 179161 | 2061377690 | K160820 | PressON Pro Spinal Fixation System | NKB | 2016-06-28 |
| 316348 | 2061377690 | K160820 | PressON Pro Spinal Fixation System | NKB | 2016-06-28 |
| 179161 | 1351113153 | K133287 | PRESSON SPINAL FIXATION SYSTEM | MNH | 2014-02-25 |
| 316348 | 1351113153 | K133287 | PRESSON SPINAL FIXATION SYSTEM | MNH | 2014-02-25 |
| 179161 | 1045492874 | K073500 | ACTIVE ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2008-07-03 |
| 316348 | 1045492874 | K073500 | ACTIVE ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2008-07-03 |
| 179161 | 1526130732 | K062371 | PREVIEW ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2006-12-04 |
| 316348 | 1526130732 | K062371 | PREVIEW ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2006-12-04 |
| 179161 | 1026867374 | ||||
| 179161 | 1390760316 | ||||
| 179161 | 1809040381 | ||||
| 316348 | 1026867374 | ||||
| 316348 | 1390760316 | ||||
| 179161 | 1498065144 | ||||
| 316348 | 1498065144 | ||||
| 316348 | 1809040381 |
Nexus Spine, LLC
Nexus Spine, LLC
Nexus Spine, LLC
Nexus Spine, LLC
Nexus Spine, LLC
Nexus Spine, LLC
Nexus Spine, LLC
Nexus Spine, LLC
Nexus Spine, LLC
Nexus Spine, LLC
Nexus Spine, LLC
Nexus Spine, LLC
Nexus Spine, LLC
Nexus Spine, LLC
Nexus Spine, LLC
Nexus Spine, LLC
NEXUS SPINE, LLC
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