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 | K193270 |
| 510k Number | K193270 |
| 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 | George Chaux |
| Correspondent | George Chaux Captiva Spine, Inc. 967 N. Alternate A1A Suite 1 Jupiter, FL 33477 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-26 |
| Decision Date | 2020-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M739243345550 | K193270 | 000 |
| M739241645300 | K193270 | 000 |
| M739241245550 | K193270 | 000 |
| M739241245500 | K193270 | 000 |
| M739241245450 | K193270 | 000 |
| M739241245400 | K193270 | 000 |
| M739241245350 | K193270 | 000 |
| M739241245300 | K193270 | 000 |
| M7391633108040 | K193270 | 000 |
| M7391613545550 | K193270 | 000 |
| M7391613545500 | K193270 | 000 |
| M7391613545450 | K193270 | 000 |
| M7391613545400 | K193270 | 000 |
| M7391613545350 | K193270 | 000 |
| M739241645350 | K193270 | 000 |
| M739241645400 | K193270 | 000 |
| M739241645450 | K193270 | 000 |
| M739243345500 | K193270 | 000 |
| M739243345450 | K193270 | 000 |
| M739243345400 | K193270 | 000 |
| M739243345350 | K193270 | 000 |
| M739243345300 | K193270 | 000 |
| M739243145550 | K193270 | 000 |
| M739243145500 | K193270 | 000 |
| M739243145450 | K193270 | 000 |
| M739243145400 | K193270 | 000 |
| M739243145350 | K193270 | 000 |
| M739243145300 | K193270 | 000 |
| M739241645550 | K193270 | 000 |
| M739241645500 | K193270 | 000 |
| M7391613545300 | K193270 | 000 |