Data / Medical devices / United States / CAPTIVA SPINE, Inc.
CAPTIVA SPINE, Inc.: FDA-registered device maker in Jupiter, FL, United States, 19 510(k) clearances
CAPTIVA SPINE, Inc. is registered with the FDA (registration 3006082533) in Jupiter, FL, United States. It lists 17 device types. The FDA files 19 510(k) clearances under its listings, the newest dated November 29, 2023. 5 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006082533
- Address
- 967 N Highway A1a Alt Ste 1, Jupiter, FL, United States, 33477
- Owner or operator
- CAPTIVA SPINE (9096708)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- December 8, 2009
- Registered through
- 2026
- Brand names listed
- CapLOX II Pedicle Screw System, CapLOX II Spinal System, CapLOX II_TowerLOX_4.5mm Screw, EquiLOX Expandable Interbody Fusion System, FuseLOX Cervical IBF, FuseLOX Cervical IBF System, FuseLOX Lumbar Interbody Fusion System, PivoTec, FuseLOX Lumbar Interbody Fusion System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Curette | HTF | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Mallet | HXL | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Osteotome, Manual | GFI | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Rongeur | HTX | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Sacroiliac Joint Fixation | OUR | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tamp | HXG | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 29, 2023 | K232069 | Expandable Lumbar Fusion Cage (Type I,Type II) | MAX | Substantially Equivalent | Shanghai Reach Medical Instrument Co, Ltd. | accessdata.fda.gov |
| January 31, 2020 | K193270 | CapLOX II®/TowerLOX® MIS Pedicle Screw System | NKB | Substantially Equivalent | Captiva Spine, Inc. | accessdata.fda.gov |
| September 19, 2018 | K181229 | TirboLOX-C Cervical IBFD | ODP | Substantially Equivalent | Captiva Spine, Inc. | accessdata.fda.gov |
| August 13, 2018 | K180990 | TirboLOX-L Lumbar IBFD | MAX | Substantially Equivalent | Captiva Spine, Inc. | accessdata.fda.gov |
| March 19, 2018 | K180475 | CapLOX II® / TowerLOX® MIS Pedicle Screw System | NKB | Substantially Equivalent | Captiva Spine, Inc. | accessdata.fda.gov |
| May 5, 2017 | K170475 | SICAGE System | OUR | Substantially Equivalent | Sicage, LLC | accessdata.fda.gov |
| March 2, 2016 | K160020 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System | MNH | Substantially Equivalent | Captiva Spine | accessdata.fda.gov |
| June 26, 2015 | K151116 | CapLOX II/TowerLOX Pedicle Screw System | MNH | Substantially Equivalent | Captiva Spine | accessdata.fda.gov |
| June 11, 2015 | K141332 | Captiva Spine SmartLOX Cervical Plate System | KWQ | Substantially Equivalent | Captiva Spine | accessdata.fda.gov |
| May 28, 2015 | K142586 | Captiva Spine FuselOX Cervical IBF System | ODP | Substantially Equivalent | Captiva Spine | accessdata.fda.gov |
| August 8, 2013 | K131538 | CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM | MNH | Substantially Equivalent | Captiva Spine | accessdata.fda.gov |
| October 25, 2012 | K122956 | FUSELOX LUMBAR INTERBODY FUSION DEVICE | MAX | Substantially Equivalent | Captiva Spine | accessdata.fda.gov |
| October 16, 2012 | K122332 | TOWERLOX PEDICLE SCREW SYSTEM | MNI | Substantially Equivalent | Captiva Spine | accessdata.fda.gov |
| April 13, 2012 | K120292 | CAPLOX II PEDICLE SCREW SYSTEM | MNI | Substantially Equivalent | Captiva Spine, Inc. | accessdata.fda.gov |
| September 13, 2011 | K111115 | CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM | MNI | Substantially Equivalent | Captiva Spine, Inc. | accessdata.fda.gov |
| March 25, 2011 | K110585 | CAPTIVA SPINE FUSELOX CERVICAL CAGE | ODP | Substantially Equivalent | Captiva Spine, Inc. | accessdata.fda.gov |
| July 9, 2010 | K100956 | SPONDY SPINAL FIXATION SYSTEM | MNH | Substantially Equivalent | Allure Spine LLC | accessdata.fda.gov |
| December 1, 2009 | K092017 | PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD) | MAX | Substantially Equivalent | Captiva Spine, Inc. | accessdata.fda.gov |
| June 3, 2008 | K073708 | FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Precision Surgery , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 25, 2015 | 70710 | Class II | Terminated | 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. | accessdata.fda.gov |
| September 20, 2012 | 63633 | Class II | Terminated | 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 s | Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking | accessdata.fda.gov |
| April 27, 2012 | 61925 | Not yet classified | Terminated | Accessories for the Captiva Spine FuseLOX Lumbar Cage. Products are labeled in part: "FuseLOX Lumbar Cage Lumbar Interbody Fusion Device***Description:***Part Number:***Lot Number:***Quantity: 1***Material: PEEK-OPTIMA L | 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. | accessdata.fda.gov |
| March 22, 2012 | 61804 | Not yet classified | Terminated | Instructions For Use: "***SmartLOX***Instructions for Use Cervical Plate System***STERILIZATION***The SmartLOX Cervical Plate System components are supplied clean and not sterile. All implants and instruments should be c | 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. | accessdata.fda.gov |
| November 22, 2011 | 61811 | Not yet classified | Terminated | Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: "***Part Number CP40012***12mm Drill Bit***Lot Number 89427-2 R***" "***Part Number CP40014***14mm Drill Bit***Lot Number 89 | 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 | accessdata.fda.gov |
Compare with other makers
- All makers of Rongeur
- All makers of Tray, Surgical, Instrument
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Appliance, Fixation, Spinal Intervertebral Body
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
Updated November 29, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.