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 |