The following data is part of a premarket notification filed by Captiva Spine, Inc. with the FDA for Tirbolox-l Lumbar Ibfd.
| Device ID | K180990 |
| 510k Number | K180990 |
| Device Name: | TirboLOX-L Lumbar IBFD |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Captiva Spine, Inc. 967 N. Alternate A1A, Suite 1 Jupiter, FL 33477 |
| Contact | Jackie Ferro |
| Correspondent | Jackie Ferro Captiva Spine, Inc. 967 N. Alternate A1A, Suite 1 Jupiter, FL 33477 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-16 |
| Decision Date | 2018-08-13 |
| Summary: | summary |