SPINAL ELEMENTS, INC.

FDA Device Registration & Listing · CARLSBAD, CA, US · Registration 3004893332

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
3004893332
FEI Number
3004893332
Entity Name
SPINAL ELEMENTS, INC.
City/State/Country
CARLSBAD, CA, US
Establishment Address
3115 Melrose Dr Suite 200, CARLSBAD, CA 92010, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Spinal Elements (Owner Number: 9048980)
Owner / Operator Contact Address
3115 Melrose Dr Suite 200, Carlsbad, CA 92010, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K071724
PMA Number
N/A

All Registered Proprietary Names

iO-Flex iO-Flex Neuro Check iO-Flex MicroBlade Shaver iO-Flex Primus Spinal Fixation System Guide Wire Depth Sounder Guide Disc Shaper Broach Hex Driver Screwdriver Temporary Fixation Pin Tap Tulip Adjuster Rod Bender Ejector Distraction Pin Driver Depth Tool Graft Block Counter Torque Set Screw Starter Post Remover Pedicle Marker Dual Stylet Needle Pin Inserter Inserter Tulip Positioner Pedicle Feeler Awl Nerver Root Retractor Access Portal Chisel Box Chisel Reducer Compactor Cannula Hex Adapter Crow Foot Distraction Pin Trial Plate Shaver Elevator Spacer Sleeve Cobb Removal Tool Tab Cutter Compressor Fulcrum Packing Block Curette Dilator Lodestar Tab Extender Plate Bender Tower Clip Pusher Crown Trephine Probe Tab Breaker Distractor Retainer Suction Tube Screw Adjuster Plate Holder Osteotome Hammer Disc Shaver Rasp Stabilizer Handle Rocker Hex Retainer Adaptor Retractor Rod Template Wrench Persuader Rongeur Disc Cutter Drill Rod Gripper Funnel Compressor Temporary Fixation Screw Caliper Sizer Nerve Sheild Tamp Rod Holder Marquise MIS Channel Karma® Fixation System Ventana™ A Anterior Lumbar Interbody System Lucent® XP Karma® Fixation System iO-Flex

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2015-03-19
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2015-03-19
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2010-12-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-12-22
HAE Rongeur, Manual Neurology Class 2 882.4840 2015-03-19
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-01-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-12-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-12-02
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-12-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-02
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2012-10-26
FST Light, Surgical, Fiberoptic General, Plastic Surgery Class 2 878.4580 2017-12-22
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2006-10-05
OWI Bone Fixation Cerclage, Sublaminar Orthopedic Class 2 888.3010 2019-04-04
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-12-05
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-06-14
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-06-01
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2017-12-22
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2017-12-22
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2018-11-28
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2018-11-28
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2018-11-28
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2018-11-28
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2018-11-28
OWI Bone Fixation Cerclage, Sublaminar Orthopedic Class 2 888.3010 2018-11-28
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2015-12-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-12-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-12-23
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2011-12-21
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2011-12-21
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-07-18
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-07-18
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-07-18
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2017-12-22
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2018-11-28
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2018-11-28
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2018-11-28
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2017-12-22
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-12-22
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2017-12-22
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-12-22
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-11-21
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-11-21
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-11-21
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2018-11-28
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2018-11-28
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2018-11-28
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2007-12-05
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2017-12-22
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2017-12-22
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2017-12-22
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-12-22
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2016-06-14
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2015-12-23
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2011-12-21
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2026-05-26
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-01-23
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2019-12-27
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-12-05
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-12-05
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-12-05
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-12-05
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2017-12-22
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-12-22
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2017-12-22
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2017-12-22
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2017-12-22
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-12-22
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-12-22
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2017-12-22
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-12-22
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-12-22
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-12-22
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2020-08-04
HRX Arthroscope Orthopedic Class 2 888.1100 2010-12-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-06-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-06-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-06-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-12-22
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2017-12-22
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2017-12-22
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-12-22
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-02-28
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-02-28
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-02-28
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-12-17
HTW Bit, Drill Orthopedic Class 1 888.4540 2012-07-24
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2010-12-20
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2012-07-24
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-01-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-01-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-01-02
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-09-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-06-14
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2016-06-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-07-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-12-22
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-12-22
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2017-12-22
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-11-28
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2017-12-22
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2017-12-22
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2012-01-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-01-03
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2010-12-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-01-12
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2017-12-22
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-12-22
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-12-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-12-22
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2016-06-14
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2017-12-22
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2025-12-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2017-12-22
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-12-22
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2017-12-22
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-12-22
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-12-23
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-11-28
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-11-28
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-12-22
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2017-12-22
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2017-12-22
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-12-22
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-12-22
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-12-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2015-12-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-12-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-12-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-12-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2018-11-28
HAE Rongeur, Manual Neurology Class 2 882.4840 2015-03-19
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-01-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-12-30
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-12-30
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2016-12-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-12-30
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-12-30
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2013-12-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-12-22
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-12-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-01-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-12-22
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2017-12-22

Official Correspondent

Sartaj Kaur-Hurrle

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Spinal Elements
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
K072702 Stryker Instruments, Instruments Div. STRYKER ANTIMIC CATHETER 2008-03-19
K833646 Edward Weck, Inc. PULSATRON NERVE LOCATOR/STIMULATOR 1984-02-10
K150005 Ndi Medical, LLC Checkpoint, Checkpoint Head & Neck 2015-02-19
K173198 U&I Corporation Facet Screw Fixation System 2018-01-03
K121850 Choicespine, LP Typhoon(TM) Facet Screw Fixation System 2012-09-20

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0023-2020 Stryker Instruments Div. of Stryker Corporation 2
C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0024-2020 Stryker Instruments Div. of Stryker Corporation 2
C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0008-2012 Osteomed, Lp 3885 Arapaho Rd Addison TX 75001 U
OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001
Z-0036-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004893332. Last updated year: 2026. Please use registration number 3004893332 when referencing this establishment in official correspondence.
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