Captiva Spine, Inc.
Captiva Spine, Inc. holds FDA 510(k) medical device clearances, first cleared 2009, most recent 2020, with 2 FDA device recalls on record.
Top product codes for Captiva Spine, Inc.
FDA recalls by Captiva Spine, Inc.
- Z-1480-2015 — Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).
- Z-0413-2013 — CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spinal System is a posterior, non-cervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Captiva Spine, Inc.
- K193270 — CapLOX II®/TowerLOX® MIS Pedicle Screw System
- K181229 — TirboLOX-C Cervical IBFD
- K180990 — TirboLOX-L Lumbar IBFD
- K180475 — CapLOX II® / TowerLOX® MIS Pedicle Screw System
- K120292 — CAPLOX II PEDICLE SCREW SYSTEM
- K111115 — CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM
- K110585 — CAPTIVA SPINE FUSELOX CERVICAL CAGE
- K092017 — PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD)
Data sourced from openFDA. This site is unofficial and independent of the FDA.