Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K253583
LUX Expandable Lumbar Interbody System · Xenix Medical · decided 2026-02-23 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| LUX Expandable Interbody System | LE1-15-102512 | XENIX MEDICAL LLC | MAX | 00840493416052 |
| LUX Expandable Interbody System | LE1-T2-004010 | XENIX MEDICAL LLC | ODP | 00840493416694 |
| LUX Expandable Interbody System | LE1-15-102210 | XENIX MEDICAL LLC | MAX | 00840493415994 |
| LUX Expandable Interbody System | LE1-T2-004008 | XENIX MEDICAL LLC | ODP | 00840493416687 |
| LUX Expandable Interbody System | LE1-A6-001300 | XENIX MEDICAL LLC | LXH | 00840493416588 |
| LUX Expandable Interbody System | LE1-00-122208 | XENIX MEDICAL LLC | MAX | 00840493416069 |
| LUX Expandable Interbody System | LE1-A4-000550 | XENIX MEDICAL LLC | LXH | 00840493416526 |
| LUX Expandable Interbody System | LE1-15-122510 | XENIX MEDICAL LLC | MAX | 00840493416137 |
| LUX Expandable Interbody System | LE1-15-102510 | XENIX MEDICAL LLC | MAX | 00840493416014 |
| LUX Expandable Interbody System | LE1-00-102508 | XENIX MEDICAL LLC | MAX | 00840493415963 |
| LUX Expandable Interbody System | LE1-08-122208 | XENIX MEDICAL LLC | MAX | 00840493416076 |
| LUX Expandable Interbody System | LE1-00-122508 | XENIX MEDICAL LLC | MAX | 00840493416083 |
| LUX Expandable Interbody System | LE1-08-102508 | XENIX MEDICAL LLC | MAX | 00840493415970 |
| LUX Expandable Interbody System | LE1-T2-004012 | XENIX MEDICAL LLC | ODP | 00840493416700 |
| LUX Expandable Interbody System | LE1-08-102510 | XENIX MEDICAL LLC | MAX | 00840493416007 |
| LUX Expandable Interbody System | LE1-08-122210 | XENIX MEDICAL LLC | MAX | 00840493416106 |
| LUX Expandable Interbody System | LE1-15-102212 | XENIX MEDICAL LLC | MAX | 00840493416038 |
| LUX Expandable Lumbar Interbody System | LE1-00-102208 | XENIX MEDICAL LLC | MAX | 00840493415949 |
| LUX Expandable Interbody System | LE1-08-122510 | XENIX MEDICAL LLC | MAX | 00840493416120 |
| LUX Expandable Interbody System | LE1-08-102212 | XENIX MEDICAL LLC | MAX | 00840493416021 |
| LUX Expandable Interbody System | LE1-08-122212 | XENIX MEDICAL LLC | MAX | 00840493416144 |
| LUX Expandable Interbody System | LE1-08-122512 | XENIX MEDICAL LLC | MAX | 00840493416168 |
| LUX Expandable Interbody System | LE1-08-122508 | XENIX MEDICAL LLC | MAX | 00840493416090 |
| LUX Expandable Interbody System | LE1-08-102208 | XENIX MEDICAL LLC | MAX | 00840493415956 |
| LUX Expandable Interbody System | LE1-15-122210 | XENIX MEDICAL LLC | MAX | 00840493416113 |