Captiva Spine, Inc
Medical device manufacturer in Jupiter, FL.
15510(k) clearances
0PMA approvals
9recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K193270 | CapLOX II®/TowerLOX® MIS Pedicle Screw SystemNKB · Special | 01/31/2020SE |
| K181229 | TirboLOX-C Cervical IBFDODP · Traditional | 09/19/2018SE |
| K180990 | TirboLOX-L Lumbar IBFDMAX · Traditional | 08/13/2018SE |
| K180475 | CapLOX II® / TowerLOX® MIS Pedicle Screw SystemNKB · Traditional | 03/19/2018SE |
| K160020 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemMNH · Special | 03/02/2016SE |
| K151116 | CapLOX II/TowerLOX Pedicle Screw SystemMNH · Special | 06/26/2015SE |
| K141332 | Captiva Spine SmartLOX Cervical Plate SystemKWQ · Traditional | 06/11/2015SE |
| K142586 | Captiva Spine FuselOX Cervical IBF SystemODP · Traditional | 05/28/2015SE |
| K131538 | Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemMNH · Special | 08/08/2013SE |
| K122956 | Fuselox Lumbar Interbody Fusion DeviceMAX · Special | 10/25/2012SE |
| K122332 | Towerlox Pedicle Screw SystemMNI · Special | 10/16/2012SE |
| K120292 | Caplox II Pedicle Screw SystemMNI · Special | 04/13/2012SE |
| K111115 | Captiva Spine Caplox II Spinal Fixation SystemMNI · Special | 09/13/2011SE |
| K110585 | Captiva Spine Fuselox Cervical CageODP · Special | 03/25/2011SE |
| K092017 | Pivotec Lumbar Interbody Fusion Device (Lifd)MAX · Traditional | 12/01/2009SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1480-2015 Class II | Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).It is possible for the titanium color-coded ring to detach from the Reamers. | 02/25/2015Terminated |
| Z-0413-2013 Class II | CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II…Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking | 09/20/2012Terminated |
| Z-1786-2012 | Accessories for the Captiva Spine FuseLOX Lumbar Cage. The FuseLOX Lumbar Inserter…Captiva Spine, Inc. initiated a recall of FuseLOX Lumbar Implants, Trials, and Inserters after FDA advised… | 04/27/2012Terminated |
| Z-1785-2012 | Accessories for the Captiva Spine FuseLOX Lumbar Cage. The Trial product is a reuseable…Captiva Spine, Inc. initiated a recall of FuseLOX Lumbar Implants, Trials, and Inserters after FDA advised… | 04/27/2012Terminated |
| Z-1784-2012 | Accessories for the Captiva Spine FuseLOX Lumbar Cage. Products are labeled in part:…Captiva Spine, Inc. initiated a recall of FuseLOX Lumbar Implants, Trials, and Inserters after FDA advised… | 04/27/2012Terminated |
| Z-1783-2012 | Accessories for the Captiva Spine FuseLOX Lumbar Cage. Products are labeled in part:…Captiva Spine, Inc. initiated a recall of FuseLOX Lumbar Implants, Trials, and Inserters after FDA advised… | 04/27/2012Terminated |
| Z-1545-2012 | Instructions For Use: "***SmartLOX***Instructions for Use Cervical Plate…Captiva Spine has initiated a correction of the SmartLOX Instructions for Use (IFU) for SmartLOX Cervical… | 03/22/2012Terminated |
| Z-1649-2012 | Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled…Captiva Spine is recalling the SmartLOX Cervical Plate components 12 & 14 mm Drill Bits, Single Barrel… | 11/22/2011Terminated |
| Z-1648-2012 | Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled…Captiva Spine is recalling the SmartLOX Cervical Plate components 12 & 14 mm Drill Bits, Single Barrel… | 11/22/2011Terminated |