Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K223412
LumiVy Lumbar IBF System · Vy Spine, LLC · decided 2023-01-06 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| LumiVy™ | 03-A-3427-6-08-PET-R | VY SPINE LLC | MAX MQP | 00840283403569 |
| LumiVy™ | 03-P-0928-0-10-PET-R | VY SPINE LLC | MAX MQP | 00840283403200 |
| LumiVy™ | 03-T-0927-0-07-PET-R | VY SPINE LLC | MAX MQP | 00840283403477 |
| LumiVy™ | 03-T-0927-0-15-PET-R | VY SPINE LLC | MAX MQP | 00840283403552 |
| LumiVy™ | 03-A-3427-6-12-PET-R | VY SPINE LLC | MAX MQP | 00840283403606 |
| LumiVy™ | 03-A-3427-6-10-PET-R | VY SPINE LLC | MAX MQP | 00840283403583 |
| LumiVy™ | 03-P-0928-0-11-PET-R | VY SPINE LLC | MAX MQP | 00840283403217 |
| LumiVy™ | 03-A-3427-6-11-PET-R | VY SPINE LLC | MAX MQP | 00840283403590 |
| LumiVy™ | 03-T-0927-0-09-PET-R | VY SPINE LLC | MAX MQP | 00840283403491 |
| LumiVy™ | 03-P-0928-0-12-PET-R | VY SPINE LLC | MAX MQP | 00840283403224 |
| LumiVy™ | 03-T-0927-0-11-PET-R | VY SPINE LLC | MAX MQP | 00840283403514 |
| LumiVy™ | 03-P-0928-0-08-PET-R | VY SPINE LLC | MAX MQP | 00840283403187 |
| LumiVy™ | 03-P-0928-0-09-PET-R | VY SPINE LLC | MAX MQP | 00840283403194 |
| LumiVy™ | 03-T-0927-0-10-PET-R | VY SPINE LLC | MAX MQP | 00840283403507 |
| LumiVy™ | 03-A-3427-6-13-PET-R | VY SPINE LLC | MAX MQP | 00840283403613 |
| LumiVy™ | 03-T-0927-0-13-PET-R | VY SPINE LLC | MAX MQP | 00840283403538 |
| LumiVy™ | 03-T-0927-0-08-PET-R | VY SPINE LLC | MAX MQP | 00840283403484 |
| LumiVy™ | 03-T-0927-0-14-PET-R | VY SPINE LLC | MAX MQP | 00840283403545 |
| LumiVy™ | 03-A-3427-6-14-PET-R | VY SPINE LLC | MAX MQP | 00840283403620 |
| LumiVy™ | 03-A-3427-6-09-PET-R | VY SPINE LLC | MAX MQP | 00840283403576 |
| LumiVy™ | 03-T-0927-0-12-PET-R | VY SPINE LLC | MAX MQP | 00840283403521 |
| LumiVy™ | 03-T-0927-0-06-PET-R | VY SPINE LLC | MAX MQP | 00840283403460 |