CAPTIVA SPINE, Inc.

FDA Device Registration & Listing · Jupiter, FL, US · Registration 3006082533

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006082533
FEI Number
3006082533
Entity Name
CAPTIVA SPINE, Inc.
City/State/Country
Jupiter, FL, US
Establishment Address
967 N HIGHWAY A1A ALT STE 1, Jupiter, FL 33477, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device
Owner / Operator
CAPTIVA SPINE (Owner Number: 9096708)
Owner / Operator Contact Address
967 Alternate A1A, SUITE 1, Jupiter, FL 33477, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Transfasten CapLOX II_TowerLOX_4.5mm Screw TowerLOX Pedicle Screw, Threshold Pedicular Fixation, CapLOX II Pedicle Screw, SmartLOX, PivoTec, FuseLox Cervical TowerLOX Pedicle Screw System, Threshold Pedicular Fixation System, CapLOX II Pedicle Screw System SmartLOX Cervical Plate System TowerLOX MIS Ext Pedicle Screw System TowerLOX Pedicle Screw, Threshold Pedicular Fixation, CapLOX II Pedicle Screw, SmartLOX, PivoTec, FuseLOX Cervical/Lumba CapLOX II Pedicle Screw System TransFasten TowerLOX Pedicle Screw System, CapLOX II Pedicle Screw System FuseLOX Lumbar Interbody Fusion System Transfasten TransFasten TowerLOX Pedicle Screw System, Threshold Pedicular Fixation System, CapLOX II Pedicle Screw System TirboLOX-C Cervical IBFD PivoTec, FuseLOX Lumbar Interbody Fusion System Pivotec CapLOX II Spinal System SmartLOX FuseLOX Cervical IBF TransFasten - LSF (Lateral Sacroiliac Fusion System) TirboLOX-L Lumbar IBFD TowerLOX Pedicle Screw System, Threshold Pedicular Fixation System, CapLOX II Pedicle Screw System EquiLOX Expandable Interbody Fusion System Pivotec, FuseLOX Lumbar Interbody Fusion System, FuseLOX Cervical IBF System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HTW Bit, Drill Orthopedic Class 1 888.4540 2019-07-25
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2020-03-02
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2009-12-08
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-08-19
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-08-19
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-10-19
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2018-05-24
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2009-12-08
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-12-13
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-12-13
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2021-08-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-09-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-09-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-12-13
HXL Mallet General, Plastic Surgery Class 1 878.4800 2019-07-25
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2019-07-25
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-12-13
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-12-13
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2019-05-20
HTF Curette General, Plastic Surgery Class 1 878.4800 2009-12-08
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2009-12-08
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2011-09-13
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2011-09-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2010-10-21
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2015-06-10
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2024-02-28
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-02-25
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-12-13
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-12-13
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-06-07
HTX Rongeur Orthopedic Class 1 888.4540 2009-12-08

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CAPTIVA SPINE
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K163363 Surgtech, Inc. SurgTech Thoracolumbosacral (TLS) Posterior Fixation System 2017-04-05
K252461 Spinal Resources, Inc. Swedge™ Pedicle Screw Fixation System Bezier Rod 2026-01-13
K140696 Pioneer Surgical Technology, Inc. STREAMLINE TL SPINAL FIXATION SYSTEM 2014-04-10
K141398 Medicrea International SA PASS LP SPINAL SYSTEM 2015-01-09
K160980 Spineology, Inc. Threshold Pedicular Fixation System, Palisade Pedicular Fixation System 2016-05-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2013 Synthes USA HQ, Inc. 2
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Z-0021-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

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3023265483 PHEN'X TECHNOLOGIES Chassieu Auvergne-Rhone-Alpes, FR
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006082533. Last updated year: 2026. Please use registration number 3006082533 when referencing this establishment in official correspondence.
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