Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K233375
Tranquil-L Interbody System · Nexus Spine, LLC · decided 2024-03-20 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Tranquil-L Interbody System | 523442s | NEXUS SPINE, L.L.C. | MAX | B678523442S0 |
| Tranquil-L™ | 523430 | NEXUS SPINE, L.L.C. | MAX | B6785234300 |
| Tranquil-L™ | 522928 | NEXUS SPINE, L.L.C. | MAX | B6785229280 |
| Tranquil-L™ | 522904 | NEXUS SPINE, L.L.C. | MAX | B6785229040 |
| Tranquil-L Interbody System | 523435s | NEXUS SPINE, L.L.C. | MAX | B678523435S0 |
| Tranquil-L™ | 523395 | NEXUS SPINE, L.L.C. | MAX | B6785233950 |
| Tranquil-L™ | 523392 | NEXUS SPINE, L.L.C. | MAX | B6785233920 |
| Tranquil-L™ | 523494 | NEXUS SPINE, L.L.C. | MAX | B6785234940 |
| Tranquil-L™ | 523470 | NEXUS SPINE, L.L.C. | MAX | B6785234700 |
| Tranquil-L™ | 523506 | NEXUS SPINE, L.L.C. | MAX | B6785235060 |
| Tranquil-L™ | 523432 | NEXUS SPINE, L.L.C. | MAX | B6785234320 |
| Tranquil-L™ | 522941 | NEXUS SPINE, L.L.C. | MAX | B6785229410 |
| Tranquil-L™ | 522069 | NEXUS SPINE, L.L.C. | MAX | B6785220690 |
| Tranquil-L™ | 522015 | NEXUS SPINE, L.L.C. | MAX | B6785220150 |
| Tranquil-L™ | 523454 | NEXUS SPINE, L.L.C. | MAX | B6785234540 |
| Tranquil-L Interbody System | 523433s | NEXUS SPINE, L.L.C. | MAX | B678523433S0 |
| Tranquil-L™ | 523445 | NEXUS SPINE, L.L.C. | MAX | B6785234450 |
| Tranquil-L™ | 523421 | NEXUS SPINE, L.L.C. | MAX | B6785234210 |
| Tranquil-L Interbody System | 522920s | NEXUS SPINE, L.L.C. | MAX | B678522920S0 |
| Tranquil-L™ | 523501 | NEXUS SPINE, L.L.C. | MAX | B6785235010 |
| Tranquil-L™ | 522002 | NEXUS SPINE, L.L.C. | MAX | B6785220020 |
| Tranquil-L™ | 522009 | NEXUS SPINE, L.L.C. | MAX | B6785220090 |
| Tranquil-L™ | 523449 | NEXUS SPINE, L.L.C. | MAX | B6785234490 |
| Tranquil-L™ | 522939 | NEXUS SPINE, L.L.C. | MAX | B6785229390 |
| Tranquil-L™ | 523469 | NEXUS SPINE, L.L.C. | MAX | B6785234690 |