Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K122956
FUSELOX LUMBAR INTERBODY FUSION DEVICE · Captiva Spine · decided 2012-10-25 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Convex Cage, 32 x 13mm | FPC3213 | CAPTIVA SPINE, INC. | MAX | M739FPC32130 |
| Convex Cage, 30 x 8mm | FPC3008 | CAPTIVA SPINE, INC. | MAX | M739FPC3008 |
| Convex Cage, 25 x 8mm | FPC2508 | CAPTIVA SPINE, INC. | MAX | M739FPC25080 |
| Lordotic Cage, 25 x 9mm | FPL2509 | CAPTIVA SPINE, INC. | MAX | M739FPL25090 |
| Lordotic Cage, 30 x 11mm | FPL3011 | CAPTIVA SPINE, INC. | MAX | M739FPL3011 |
| Convex Cage, 30 x 11mm | FPC3011 | CAPTIVA SPINE, INC. | MAX | M739FPC3011 |
| Convex Cage, 30 x 10mm | FPC3010 | CAPTIVA SPINE, INC. | MAX | M739FPC30100 |
| Convex Cage, 32 x 12mm | FPC3212 | CAPTIVA SPINE, INC. | MAX | M739FPC3212 |
| Lordotic Cage, 32 x 13mm | FPL3213 | CAPTIVA SPINE, INC. | MAX | M739FPL3213 |
| Convex Cage, 30 x 11mm | FPC3011 | CAPTIVA SPINE, INC. | MAX | M739FPC30110 |
| Convex Cage, 28 x 14mm | FPC2814 | CAPTIVA SPINE, INC. | MAX | M739FPC2814 |
| Convex Cage, 25 x 10mm | FPC2510 | CAPTIVA SPINE, INC. | MAX | M739FPC25100 |
| Lordotic Cage, 25 x 10mm | FPL2510 | CAPTIVA SPINE, INC. | MAX | M739FPL2510 |
| Convex Cage, 32 x 11mm | FPC3211 | CAPTIVA SPINE, INC. | MAX | M739FPC32110 |
| Lordotic Cage, 28 x 10mm | FPL2810 | CAPTIVA SPINE, INC. | MAX | M739FPL2810 |
| Convex Cage, 28 x 9mm | FPC2809 | CAPTIVA SPINE, INC. | MAX | M739FPC2809 |
| Convex Cage, 28 x 11mm | FPC2811 | CAPTIVA SPINE, INC. | MAX | M739FPC2811 |
| Lordotic Cage, 30 x 10mm | FPL3010 | CAPTIVA SPINE, INC. | MAX | M739FPL3010 |
| Lordotic Cage, 25 x 11mm | FPL2511 | CAPTIVA SPINE, INC. | MAX | M739FPL25110 |
| Convex Cage, 25 x 14mm | FPC2514 | CAPTIVA SPINE, INC. | MAX | M739FPC25140 |
| Convex Cage, 32 x 8mm | FPC3208 | CAPTIVA SPINE, INC. | MAX | M739FPC3208 |
| Convex Cage, 30 x 12mm | FPC3012 | CAPTIVA SPINE, INC. | MAX | M739FPC30120 |
| Convex Cage, 25 x 14mm | FPC2514 | CAPTIVA SPINE, INC. | MAX | M739FPC2514 |
| Convex Cage, 25 x 7mm | FPC2507 | CAPTIVA SPINE, INC. | MAX | M739FPC2507 |
| Convex Cage, 32 x 13mm | FPC3213 | CAPTIVA SPINE, INC. | MAX | M739FPC3213 |