The following data is part of a premarket notification filed by Captiva Spine, Inc. with the FDA for Caplox Ii® / Towerlox® Mis Pedicle Screw System.
| Device ID | K180475 |
| 510k Number | K180475 |
| Device Name: | CapLOX II® / TowerLOX® MIS Pedicle Screw System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Captiva Spine, Inc. 967 N. Alternate A1A, Suite 1 Jupiter, FL 33477 |
| Contact | Jackie Ferro |
| Correspondent | Jackie Ferro Captiva Spine, Inc. 967 North Alternate A1A, Suite 1 Jupiter, FL 33477 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-22 |
| Decision Date | 2018-03-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M7391613585950 | K180475 | 000 |
| M7391613585900 | K180475 | 000 |
| M7391613580400 | K180475 | 000 |
| M7391613580350 | K180475 | 000 |
| M7391613565750 | K180475 | 000 |
| M7391613565700 | K180475 | 000 |
| M7391613555550 | K180475 | 000 |
| M7391613549501 | K180475 | 000 |