Captiva Spine, Inc
FDA Regulatory Profile
Captiva Spine, Inc appears in FDA public data with 2 recalls, 15 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1480-2015, Class II) was initiated on February 25, 2015. Its most recent 510(k) clearance was granted on January 31, 2020.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 15
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1480-2015 | Class II | Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers). | February 25, 2015 |
| Z-0413-2013 | Class II | CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spinal S | September 20, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K193270 | CapLOX II®/TowerLOX® MIS Pedicle Screw System | January 31, 2020 |
| K181229 | TirboLOX-C Cervical IBFD | September 19, 2018 |
| K180990 | TirboLOX-L Lumbar IBFD | August 13, 2018 |
| K180475 | CapLOX II® / TowerLOX® MIS Pedicle Screw System | March 19, 2018 |
| K160020 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System | March 2, 2016 |
| K151116 | CapLOX II/TowerLOX Pedicle Screw System | June 26, 2015 |
| K141332 | Captiva Spine SmartLOX Cervical Plate System | June 11, 2015 |
| K142586 | Captiva Spine FuselOX Cervical IBF System | May 28, 2015 |
| K131538 | CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM | August 8, 2013 |
| K122956 | FUSELOX LUMBAR INTERBODY FUSION DEVICE | October 25, 2012 |
| K122332 | TOWERLOX PEDICLE SCREW SYSTEM | October 16, 2012 |
| K120292 | CAPLOX II PEDICLE SCREW SYSTEM | April 13, 2012 |
| K111115 | CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM | September 13, 2011 |
| K110585 | CAPTIVA SPINE FUSELOX CERVICAL CAGE | March 25, 2011 |
| K092017 | PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD) | December 1, 2009 |