The following data is part of a premarket notification filed by Captiva Spine with the FDA for Fuselox Lumbar Interbody Fusion Device.
| Device ID | K122956 |
| 510k Number | K122956 |
| Device Name: | FUSELOX LUMBAR INTERBODY FUSION DEVICE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | CAPTIVA SPINE 13540 GUILD AVE Apple Vally, MN 55124 |
| Contact | Rich Jansen |
| Correspondent | Rich Jansen CAPTIVA SPINE 13540 GUILD AVE Apple Vally, MN 55124 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-25 |
| Decision Date | 2012-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M739FPC3207 | K122956 | 000 |
| M739FPC3008 | K122956 | 000 |
| M739FPC30070 | K122956 | 000 |
| M739FPC3007 | K122956 | 000 |
| M739FPC28140 | K122956 | 000 |
| M739FPC2814 | K122956 | 000 |
| M739FPC28130 | K122956 | 000 |
| M739FPC2813 | K122956 | 000 |
| M739FPC28120 | K122956 | 000 |
| M739FPC2812 | K122956 | 000 |
| M739FPC28110 | K122956 | 000 |
| M739FPC30080 | K122956 | 000 |
| M739FPC3009 | K122956 | 000 |
| M739FPC30090 | K122956 | 000 |
| M739FPC30140 | K122956 | 000 |
| M739FPC3014 | K122956 | 000 |
| M739FPC30130 | K122956 | 000 |
| M739FPC3013 | K122956 | 000 |
| M739FPC30120 | K122956 | 000 |
| M739FPC3012 | K122956 | 000 |
| M739FPC30110 | K122956 | 000 |
| M739FPC3011 | K122956 | 000 |
| M739FPC30100 | K122956 | 000 |
| M739FPC3010 | K122956 | 000 |
| M739FPC2811 | K122956 | 000 |
| M739FPC28100 | K122956 | 000 |
| M739FPC25110 | K122956 | 000 |
| M739FPC2511 | K122956 | 000 |
| M739FPC25100 | K122956 | 000 |
| M739FPC2510 | K122956 | 000 |
| M739FPC25090 | K122956 | 000 |
| M739FPC2509 | K122956 | 000 |
| M739FPC25080 | K122956 | 000 |
| M739FPC2508 | K122956 | 000 |
| M739FPC25070 | K122956 | 000 |
| M739FPC2507 | K122956 | 000 |
| M739FPC2512 | K122956 | 000 |
| M739FPC25120 | K122956 | 000 |
| M739FPC2513 | K122956 | 000 |
| M739FPC2810 | K122956 | 000 |
| M739FPC28090 | K122956 | 000 |
| M739FPC2809 | K122956 | 000 |
| M739FPC28080 | K122956 | 000 |
| M739FPC2808 | K122956 | 000 |
| M739FPC28070 | K122956 | 000 |
| M739FPC2807 | K122956 | 000 |
| M739FPC25140 | K122956 | 000 |
| M739FPC2514 | K122956 | 000 |
| M739FPC25130 | K122956 | 000 |
| M739FL25130 | K122956 | 000 |
| M739FPL3213 | K122956 | 000 |
| M739FPL2813 | K122956 | 000 |
| M739FPL2812 | K122956 | 000 |
| M739FPL2811 | K122956 | 000 |
| M739FPL2810 | K122956 | 000 |
| M739FPL2809 | K122956 | 000 |
| M739FPL2808 | K122956 | 000 |
| M739FPL2807 | K122956 | 000 |
| M739FPL25130 | K122956 | 000 |
| M739FPL2513 | K122956 | 000 |
| M739FPL25120 | K122956 | 000 |
| M739FPL3007 | K122956 | 000 |
| M739FPL3008 | K122956 | 000 |
| M739FPL3009 | K122956 | 000 |
| M739FPL3212 | K122956 | 000 |
| M739FPL3211 | K122956 | 000 |
| M739FPL3210 | K122956 | 000 |
| M739FPL3209 | K122956 | 000 |
| M739FPL3208 | K122956 | 000 |
| M739FPL3207 | K122956 | 000 |
| M739FPL3013 | K122956 | 000 |
| M739FPL3012 | K122956 | 000 |
| M739FPL3011 | K122956 | 000 |
| M739FPL3010 | K122956 | 000 |
| M739FPL2512 | K122956 | 000 |
| M739FPL25110 | K122956 | 000 |
| M739FPC32120 | K122956 | 000 |
| M739FPC3212 | K122956 | 000 |
| M739FPC32110 | K122956 | 000 |
| M739FPC3211 | K122956 | 000 |
| M739FPC32100 | K122956 | 000 |
| M739FPC3210 | K122956 | 000 |
| M739FPC32090 | K122956 | 000 |
| M739FPC3209 | K122956 | 000 |
| M739FPC32080 | K122956 | 000 |
| M739FPC3208 | K122956 | 000 |
| M739FPC3213 | K122956 | 000 |
| M739FPC32130 | K122956 | 000 |
| M739FPC3214 | K122956 | 000 |
| M739FPL2511 | K122956 | 000 |
| M739FPL25100 | K122956 | 000 |
| M739FPL2510 | K122956 | 000 |
| M739FPL25090 | K122956 | 000 |
| M739FPL2509 | K122956 | 000 |
| M739FPL25080 | K122956 | 000 |
| M739FPL2508 | K122956 | 000 |
| M739FPL25070 | K122956 | 000 |
| M739FPL2507 | K122956 | 000 |
| M739FPC32140 | K122956 | 000 |
| M739FPC32070 | K122956 | 000 |