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Captiva Spine, Inc

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
15
Inspections
6
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1480-2015Class IICaptiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).February 25, 2015
Z-0413-2013Class IICapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spinal SSeptember 20, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemJanuary 31, 2020
K181229TirboLOX-C Cervical IBFDSeptember 19, 2018
K180990TirboLOX-L Lumbar IBFDAugust 13, 2018
K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemMarch 19, 2018
K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemMarch 2, 2016
K151116CapLOX II/TowerLOX Pedicle Screw SystemJune 26, 2015
K141332Captiva Spine SmartLOX Cervical Plate SystemJune 11, 2015
K142586Captiva Spine FuselOX Cervical IBF SystemMay 28, 2015
K131538CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEMAugust 8, 2013
K122956FUSELOX LUMBAR INTERBODY FUSION DEVICEOctober 25, 2012
K122332TOWERLOX PEDICLE SCREW SYSTEMOctober 16, 2012
K120292CAPLOX II PEDICLE SCREW SYSTEMApril 13, 2012
K111115CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEMSeptember 13, 2011
K110585CAPTIVA SPINE FUSELOX CERVICAL CAGEMarch 25, 2011
K092017PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD)December 1, 2009