Captiva Spine
United Statesfrom the FDA registration address FDA FEI 3006082533
Captiva Spine is a medical device manufacturer, with 4,465 devices listed and 9 FDA recalls as of 12 Nov 2026.
- Devices
- 4,465
- Registrations
- FDA
- FDA recalls
- 9
Registry facts
- Registries
- FDA GUDID 3,000
- Device classes
- FDA Class II 2,675
- FDA Class I 325
- FDA recalls
- Identifiers
- FDA FEI 3006082533
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
Catalogue
Search and filter all 4,465 devicesShowing 1-50 of 4,465
Company details
- FDA FEI number
- 3006082533
- Address
- 967 N HIGHWAY A1A ALT STE 1, Jupiter, FL, 33477
FDA recalls
2015
- 25 Feb 2015 Z-1480-2015 Class II Terminated It is possible for the titanium color-coded ring to detach from the Reamers.
2012
- 20 Sep 2012 Z-0413-2013 Class II Terminated Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking
- 27 Apr 2012 Z-1783-2012 Not yet classified Terminated Captiva Spine, Inc. initiated a recall of FuseLOX Lumbar Implants, Trials, and Inserters after FDA advised the firm that there is inadequate support for implemented design changes to the cleared device Pivotec Lumbar Interbody Fusion Device.
- 27 Apr 2012 Z-1784-2012 Not yet classified Terminated Captiva Spine, Inc. initiated a recall of FuseLOX Lumbar Implants, Trials, and Inserters after FDA advised the firm that there is inadequate support for implemented design changes to the cleared device Pivotec Lumbar Interbody Fusion Device.
- 27 Apr 2012 Z-1785-2012 Not yet classified Terminated Captiva Spine, Inc. initiated a recall of FuseLOX Lumbar Implants, Trials, and Inserters after FDA advised the firm that there is inadequate support for implemented design changes to the cleared device Pivotec Lumbar Interbody Fusion Device.
- 27 Apr 2012 Z-1786-2012 Not yet classified Terminated Captiva Spine, Inc. initiated a recall of FuseLOX Lumbar Implants, Trials, and Inserters after FDA advised the firm that there is inadequate support for implemented design changes to the cleared device Pivotec Lumbar Interbody Fusion Device.
- 22 Mar 2012 Z-1545-2012 Not yet classified Terminated Captiva Spine has initiated a correction of the SmartLOX Instructions for Use (IFU) for SmartLOX Cervical Plate System. The pre vacuum sterilization cycle [270 (132 C) for 3 minutes] has not been validated.
2011
- 22 Nov 2011 Z-1648-2012 Unclassified (pre-2012) Terminated Captiva Spine is recalling the SmartLOX Cervical Plate components 12 & 14 mm Drill Bits, Single Barrel Variable Drill Guides, and Double Barrel Fixed Drill Guides. The components are part of the instrumentation kit used to complete an anterior screw fixation of the cervical spine. There is a potential risk for the drills to not properly fit through the drill guides due to an overlap in the dime
- 22 Nov 2011 Z-1649-2012 Unclassified (pre-2012) Terminated Captiva Spine is recalling the SmartLOX Cervical Plate components 12 & 14 mm Drill Bits, Single Barrel Variable Drill Guides, and Double Barrel Fixed Drill Guides. The components are part of the instrumentation kit used to complete an anterior screw fixation of the cervical spine. There is a potential risk for the drills to not properly fit through the drill guides due to an overlap in the dime
Frequently asked questions
How many devices does Captiva Spine have in the registry?
The registry currently lists 4465 devices for Captiva Spine. Devices recorded under merged duplicate company entries are counted once.
Which registries list Captiva Spine's devices?
Among its 50 most recently registered devices, Captiva Spine has devices listed in FDA GUDID (50 devices).
What risk classes do Captiva Spine's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Captiva Spine's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Captiva Spine?
FDA recall records list 9 recalls initiated by Captiva Spine, the most recent initiated on 25 Feb 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Captiva Spine in the registry?
The most recently registered devices listed for Captiva Spine include Non-Modular Convex Trial 19399-0906, Nav Instruments General Tray 22300-0700, Marking Pin 98520-2229 and SG Implant Driver-S 24399-9005.