Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Captiva Spine, Inc. with 15 510(k) clearances and 2 device recalls. The most recent is a 510(k) clearance dated Jan 31, 2020: CapLOX II®/TowerLOX® MIS Pedicle Screw System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jan 31, 2020 | CapLOX II®/TowerLOX® MIS Pedicle Screw SystemK193270 · NKB | 510(k) clearances |
| Sep 19, 2018 | TirboLOX-C Cervical IBFDK181229 · ODP | 510(k) clearances |
| Aug 13, 2018 | TirboLOX-L Lumbar IBFDK180990 · MAX | 510(k) clearances |
| Mar 19, 2018 | CapLOX II® / TowerLOX® MIS Pedicle Screw SystemK180475 · NKB | 510(k) clearances |
| Mar 2, 2016 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemK160020 · MNH | 510(k) clearances |
| Jun 26, 2015 | CapLOX II/TowerLOX Pedicle Screw SystemK151116 · MNH | 510(k) clearances |
| Jun 11, 2015 | Captiva Spine SmartLOX Cervical Plate SystemK141332 · KWQ | 510(k) clearances |
| May 28, 2015 | Captiva Spine FuselOX Cervical IBF SystemK142586 · ODP | 510(k) clearances |
| Feb 25, 2015 | Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).Class II · It is possible for the titanium color-coded ring to detach from the Reamers. | Device recalls |
| Sep 20, 2012 | CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spinal System is a posterior, non-cervical pedicClass II · Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
