Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2031966

FEI Number

3002980729

Entity Name

NUVASIVE, INC.

City/State/Country

SAN DIEGO, CA, US

Establishment Address

7475 Lusk Blvd, SAN DIEGO, CA 92121, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NUVASIVE, INC. (Owner Number: 9036345)

Owner / Operator Contact Address

2560 General Armistead Ave, VALLEY FORGE BUSINESS CENTER, Audubon, PA 19403, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K150474

PMA Number

N/A

All Registered Proprietary Names

NuVasive® CoRoent® Small Ti-C System NuVasive® Modulus® ALIF System NV M5 System NuVasive MaXcess Light Guide CoRoent Small & SHL Interbody System EXTRACTOR NUVASIVE COROENT EXTENSURE SYSTEM CoRoent Zero-Profile System X-Core ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM NuVasive GSB Global Spinal Balance System NuVasive® Cohere® Thoracolumbar Interbody System NuVasive® Modulus TLIF Interbody System NuVasive StruXureFixation System NuVasive® Reline® System XLP Lateral Plate NuVasive Thoracolumbar Plates Armada Spinal Fixation system NuVasive Navigation Instruments Awl Affix Spinous Process Plate System FormaGraft Collagen Bone Graft Matrix AffiX Next Gen Spinous Process Plate System Wrench NuVasive® Sterilization Trays Bendini Cloud Application NuVasive® Thoracolumbar Interbody Systems NuVasive® AttraX Scaffold BIT, DRILL NuVasive® Cohere® Thoracolumbar Interbody System NuVasive® Reline® 4.5-5 System BRIGADE ANTERIOR PLATE SYSTEM NuVasive Pulse System NUVASIVE EMBRACE SYSTEM NuVasive® Precept Spinal System CoRoent Small Contoured Interbody System NuVasive Cohere ALIF System Intervertebral Body Fusion Device NuVasive® Interfixated Interbody System COROENT XL STERILE NuVasive CoRoent Ti-C System NuVasive NVM5 System NuVasive SpheRx Spinal System NuVasive® CoRoent® Small Interbody System Rod Registration Frame NuVasive® PEEK Corpectomy System ELECTRODE CABLE OR HARNESS NuVasive® VuePoint® II OCT System Helix-T Anterior Cervical Plating System NuVasive Reline System Archon-R ACP System SpheRx PPS System VuePoint OCT System NuVasive Polyaxial Spinal Screws NuVasive® MOD-EX XLIF Interbody System NuVasive CoRoent® Small Interbody System Traverse Lateral Plate System NuVasive® 3DP Interfixated ALIF System NUVASIVE MESH NuVasive Precept Spinal System NUVASIVE NV JJB SYSTEM NV JJB System NuVasive NVM5 System NuVasive® Navigation Instruments CoRoent XL-F System MLX - Medial Lateral Expandable Lumbar Interbody NuVasive X-Core® Expandable VBR System, NuVasive X-Core® Mini Cervical Expandable VBR System SpheRx DBR II System CoRoent Thoracolumbar Implants Brigade ALIF Plate NuVasive CoRoent Single Tab System NuVasive Lumbar Interbody Implants NUVASIVE MESH GAUGE, DEPTH Affix II Spinous Process Plate System NuVasive Propel DBM Putty and Gel Plus NuVasive ET TUBE NuVasive NVM5 System DRIVER, PROSTHESIS Vertera SpineTM Cohere® Cervical Interbody Fusion Device Mallet Retractor NuVasive® Growth Rod Conversion Set NuVasive Bendini Spinal Rod Bending System Vertera Spine Coalesce Thoracolumbar Interbody Fusion System NuVasive® Pulse System CoRoent S Interbody System NV JJB SYSTEM NuVasive® VersaTie System Simplify® Cervical Artificial Disc NuVasive® XLX Interbody System NuVasive SpheRx II Spinal System NuVasive® Camber Laminoplasty System Armada Spinal Fixation system NuVasive TLX Interbody System NuVasive ALIF Buttress Plate System NuVasive® AttraX® Putty NuVasive® CoRoent® Small Interlock System SpheRx PPS Beta System NuVasive® RELINE® Fenestrated Screws, High V+ Bone Cement NuVasive® Foundation-LL System NuVasive X-Core Expandable VBR System NuVasive Triad Facet Screw System XLP Lateral Plate System Instrument, Compression NuVasive® Modulus XLIF Interbody System NuVasive® ACP System Armada Spinal Fixation system NuVasive® Lumbar Interbody Implants XLIF Stimulating Electrode SpheRx Spinal System NuVasive® ACP System NuVasive® Cohere® Thoracolumbar Interbody System Vertera Spine Cohere Cervical Interbody Fusion Device NuVasive ET TUBE NUVASIVE COROENT L & XL SYSTEMS XLP II Lateral Plate NUVASIVE COROENT SYSTEM NuVasive® Thoracolumbar Interbody Systems NuVasive® NuvaLineTM Mobile App System, x-ray, film marking, radiographic NuVasive Lateral VBR System Helix Mini Anterior Cervical Plating System NuVasive RELINE Cervical System NuVasive Reline System (Pediatric Indications) NuVasive® BASE Interfixated Titanium System NuVasive® CoRoent® Small Interlock System NuVasive® CoRoent® Lumbar Sytem NuVasive® MLX - Medial Lateral Expandable Lumbar Interbody System, NuVasive® AP Expandable XLIF System NuVasive® Brigade® Lateral System NuVasive CoRoent System (Degenerative Scoliosis) NuVasive® Modulus XLIF Interbody System NV JJB System NuVasive AttraX Scaffold NuVasive® Anterior Cervical Plate Systems PIN TRACTION NuVasive NVM5 System NuVasive PCM Cervical Disc NuVasive® CoRoent® Thoracolumbar System NuVasive NV EMG Endotracheal Tube NuVasive CoRoent System VuePoint OCT System MLX-Medial Lateral Expandable Lumbar Interbody System Brigade XLR STANDALONE SYSTEM NuVasive NV M5 NuVasive® VersaTie System CoRoent Small Interlock II System CoRoent Small Interlock System CoRoent Small Ti-C System CoRoent Small Contoured Interbody System Cohere Cervical Interbody System CoRoent Small Interbody System NuVasive® ACP System NuVasive Expandable Lumbar Interbody System Traverse 2 Bolt Lateral Plate System NuVasive NVJJB System Bendini Spinal Rod Bending System NuVasive CoRoent Small Interlock System (Allograft) COROENT TITANIUM SYSTEM NuVasive VuePoint OCT System NuVasive Propel DBM Putty CoRoent® Ti-C System NuVasive Affix Spinous Process Plate System NuVasive Next Generation NVM5 System NuVasive® TLX Interbody System NuVasive AP Expandable XLIF System NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2 Interbody System Decade Lateral Plate System Bipolar Coagulating Forceps NuVasive® VuePoint® II OCT System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2016-10-28
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2021-03-02
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2012-06-19
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2006-10-17
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2014-05-14
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2014-05-14
HWB	Extractor	Orthopedic	Class 1	888.4540	2016-04-05
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2008-03-27
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2012-06-19
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2012-06-19
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2012-06-19
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-11-04
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-11-04
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-11-04
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-11-04
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-11-04
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2020-04-06
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2020-04-06
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2017-11-17
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2017-11-17
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-04-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2016-10-27
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2016-10-27
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2016-10-27
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2016-10-27
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2016-10-27
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2016-10-27
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-06-20
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2020-06-04
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-06-19
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2012-06-19
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2012-06-19
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2012-06-19
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2012-06-19
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2020-12-03
HWJ	Awl	Orthopedic	Class 1	888.4540	2016-04-15
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2012-06-19
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2007-02-26
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2014-01-14
HXC	Wrench	Orthopedic	Class 1	888.4540	2016-04-15
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2015-08-31
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-09-26
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2020-10-12
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2020-10-12
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2020-10-12
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2018-01-25
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2016-04-05
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2018-12-04
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2018-12-04
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2017-04-17
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2017-04-17
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2017-04-17
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-08-15
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2021-09-03
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2021-09-03
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2021-09-03
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2021-09-03
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2021-09-03
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2021-09-03
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2021-09-03
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-09-03
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2021-09-03
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2010-10-21
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2017-11-17
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2017-11-17
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2017-11-17
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2014-11-06
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2022-11-03
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2016-04-21
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2014-01-14
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2014-01-14
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2017-05-15
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2016-01-15
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2016-01-15
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2016-01-15
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2016-01-15
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2016-01-15
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2016-01-15
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2008-03-27
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2008-03-27
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2008-03-27
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2008-03-27
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2017-04-17
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-05-08
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2015-09-10
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2006-11-02
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2018-03-16
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2018-03-16
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-06-19
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2015-05-08
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2015-05-08
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-05-08
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2015-05-08
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-05-08
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2015-05-08
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-10-15
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-06-19
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2012-06-19
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2012-06-19
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2012-06-19
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2012-06-19
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2012-06-19
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-09-10
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2012-09-10
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2012-09-10
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2012-09-10
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2012-09-10
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-05-13
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2021-05-13
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2021-05-13
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2015-06-16
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-06-19
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2020-04-02
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2008-03-27
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2012-09-20
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2012-09-20
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2012-09-20
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-09-20
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2012-09-20
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2008-03-28
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2008-03-28
INK	Stretcher, Wheeled, Powered	Physical Medicine	Class 2	890.3690	2012-06-20
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2012-06-20
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2015-05-08
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2015-05-08
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2015-05-08
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2015-05-08
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2015-05-08
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2015-05-08
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-05-06
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2018-01-25
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2014-08-08
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2014-08-08
PLR	Spinal Vertebral Body Replacement Device - Cervical	Orthopedic	Class 2	888.3060	2020-03-03
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2020-03-03
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2012-06-19
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2012-06-19
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-06-19
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2012-06-19
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2012-06-19
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2014-08-08
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2014-08-08
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2014-08-08
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-06-19
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2013-11-20
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2013-11-20
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2016-04-06
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2016-04-06
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2008-03-27
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2016-04-05
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2014-01-14
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2018-10-17
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2018-10-17
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2014-05-14
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2014-05-14
BSK	Cuff, Tracheal Tube, Inflatable	Anesthesiology	Class 2	868.5750	2014-05-14
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2012-06-19
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2012-06-19
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2012-06-19
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2012-06-19
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2016-04-05
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2018-01-25
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2016-04-15
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2016-04-15
PGM	Growing Rod System	Orthopedic	Class 2	888.3070	2017-11-17
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2012-12-14
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2018-01-25
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2018-01-25
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2018-07-03
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2018-07-03
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2018-07-03
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2018-07-03
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2018-07-03
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2018-07-03
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2018-07-03
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-07-03
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2018-07-03
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2012-06-19
BXM	Stimulator, Nerve, Ac-Powered	Anesthesiology	Class 2	868.2775	2008-03-27
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2018-01-25
MJO	Prosthesis, Intervertebral Disc	Unknown	Class 3	N/A	2022-05-10
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2018-05-07
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2018-05-07
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2018-05-07
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-06-20
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2012-06-20
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2012-06-20
NQW	Orthosis, Spine, Plate, Laminoplasty, Metal	Orthopedic	Class 2	888.3050	2019-09-20
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2006-10-17
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2006-10-17
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2006-10-17
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2006-10-17
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2006-10-17
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2016-04-06
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2015-04-15
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2019-11-04
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2016-10-27
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2012-06-19
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2012-06-19
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2012-06-19
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-06-19
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2012-06-19
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2018-12-04
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2018-12-04
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2018-12-04
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2015-12-03
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2015-05-08
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2006-10-17
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-06-20
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2016-04-15
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2017-11-17
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2017-11-17
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2017-11-17
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-09-20
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2012-06-20
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2012-06-20
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2012-06-20
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-06-20
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2012-06-20
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2016-08-26
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2016-08-26
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2012-06-19
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-06-20
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2020-12-04
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2021-12-23
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2021-12-23
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-12-23
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2021-12-23
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2017-10-05
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2012-06-19
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2012-06-19
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2008-03-27
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2008-03-27
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-06-19
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2008-03-27
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2021-01-21
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-01-21
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2021-01-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-05-15
JAC	System, X-Ray, Film Marking, Radiographic	Radiology	Class 1	892.1640	2016-03-16
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2014-11-06
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-06-19
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2022-05-10
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2022-05-10
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2015-05-08
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2015-05-08
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-05-08
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-05-08
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2015-05-08
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2015-05-08
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2017-04-27
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2019-11-15
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2015-10-06
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2015-08-31
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2018-08-31
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2015-05-08
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2017-04-05
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2017-04-05
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2012-06-20
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2024-09-26
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2021-11-03
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2010-11-29
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2015-04-15
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2015-04-15
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2015-04-15
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2015-04-15
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2015-04-15
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2015-04-15
MJO	Prosthesis, Intervertebral Disc	Unknown	Class 3	N/A	2012-11-26
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2017-06-27
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2017-06-27
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2012-06-19
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2015-04-15
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2012-06-19
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2016-07-12
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2012-06-19
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2012-06-19
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2014-06-17
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2014-06-17
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2014-06-17
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2014-06-17
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2014-06-17
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2014-06-17
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2016-07-15
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2023-07-12
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2023-07-12
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2020-06-03
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2013-10-21
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-06-19
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2012-06-19
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2012-06-19
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2012-06-19
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2012-06-19
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2015-05-08
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2012-06-29
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2012-06-29
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2016-01-15
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2016-01-15
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2015-07-01
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2015-07-01
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2016-07-11
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2013-10-21
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-04-17
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2017-04-17
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2017-04-17
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-04-17
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2017-04-17
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2017-04-17
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2017-11-17
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2017-11-17
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-11-07
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2016-11-07
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2016-11-07
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2014-08-05
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2022-06-23
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2022-06-23
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-06-23
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2022-06-23
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-10-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-06-26
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-11-02
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2015-11-02

Official Correspondent

Daniel Paul

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NUVASIVE, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006179046	NuVasive Specialized Orthopedics, Inc.	Audubon, PA, US
3009144915	NUVASIVE, INC.	Guaynabo, PR, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K142269	Reliance Medical Systems, LLC	Reliance Cervical IBF System	2015-06-09
K122085	Omni Surgical, LP Dba Spine360	STINGRAY CERVICAL CAGE	2012-10-17
K120275	Synthes (Usa), LLC	SYNTHES ACIS/VERTEBRAL SPACER CR	2012-05-25
K192492	Astura Medical, LLC	EL CAPITAN Anterior Lumber Interbody System	2020-04-21
K212498	Nexus Spine, LLC	Stable-L Standalone Lumbar Interbody System	2022-03-18

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.

Similar Registrations

Registration Number	Establishment Name	Location
3021588295	XYRESIC LLC	Jackson, MI, US
3036496433	SPECTRUM SPINE INC	Jasper, GA, US
3027726367	HAPPE SPINE	Grand Rapids, MI, US
3027201862	XCIX DESIGN, LLC	Richmond, UT, US
3017936978	CARLSMED, INC.	Carlsbad, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2031966. Last updated year: 2026. Please use registration number 2031966 when referencing this establishment in official correspondence.