Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009144915

FEI Number

3009144915

Entity Name

NUVASIVE, INC.

City/State/Country

Guaynabo, PR, US

Establishment Address

City View Plaza 1 Suites 116 & 117, #48 Rd 165 Km 1.2, Guaynabo, PR 00968, 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

K210271

PMA Number

N/A

All Registered Proprietary Names

NuVasive® Modulus XLIF Interbody System NuVasive® Modulus-C Interbody System Precice® Bone Transport System LessRay® System NuVasive® CoRoent® Thoracolumbar System NuVasive® RELINE® Fenestrated Screws, High V+ Bone Cement NuVasive® NuvaLineTM Mobile App NuVasive VersaTie System NuVasive Cohere ALIF System Intervertebral Body Fusion Device NuVasive® Monolith Corpectomy System Simplify® Disc Inserter FP NuVasive Pulse System NuVasive MaXcess Light Guide NuVasive® Pulse System NuVasive® BASE Interfixated Titanium System PRECICE® Bone Transport System PRECICE Bone Transport System PRECICE® STRYDE PRECICE Intramedullary Limb Lengthening System NuVasive Navigation Instruments NuVasive® Cohere® Thoracolumbar Interbody System NuVasive Thoracolumbar Plates Precice® Instrument NuVasive Modulus XLIF Interbody System NuVasive® Modulus® XLIF Interbody System NuVasive® Cohere® Thoracolumbar Interbody System FormaGraft Collagen Bone Graft Matrix NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2 Interbody System NuVasive RELINE Cervical System Precice® Ankle Salvage 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® 3DP Interfixated ALIF System General Instruments NuVasive® ACP System Simplify® Cervical Artificial Disc External Remote Controller ERC 4P NuVasive® Navigation Instruments ELECTRODE CABLE OR HARNESS Precice Intramedullary Limb Lengthening System Vertera Spine Coalesce Thoracolumbar Interbody Fusion System NuVasive® MLX® - Medial Lateral Expandable Lumbar Interbody System, NuVasive® AP Expandable XLIF System NuVasive® Precept Spinal System NuVasive® Monolith Cervical Corpectomy System MANUAL SURGICAL INSTRUMENTS PRECICE ERC 4P NuVasive® VuePoint® II OCT System NuVasive® Cohere® Thoracolumbar Interbody System NV JJB SYSTEMS Vertera SpineTM Cohere® Cervical Interbody Fusion Device Precice® Plating System Precice Ankle Salvage System NuVasive® Anterior Cervical Plate Systems NuVasive® Thoracolumbar Interbody Systems NuVasive RELINE System NuVasive X-Core® Expandable VBR System, NuVasive X-Core® Mini Cervical Expandable VBR System NuVasive® Thoracolumbar Interbody Systems NuVasive® ACP System NuVasive® Growth Rod Conversion Set NuVasive CoRoent Small Interlock II System NuVasive® LessRay® with Enhanced Tracking NuVasive® Modulus-C Interbody System Rod Registration Frame NuVasive Modulus ALIF System MAGEC® System NuVasive® Brigade® Lateral System NuVasive® MOD-EX XLIF Interbody System NuVasive® AttraX Scaffold NuVasive® Reline® 4.5-5 System NuVasive Reline System NuVasive® VersaTie System NuVasive® CoRoent® Small Interlock System Coalesce Lumbar Interbody Fusion System NuVasive® Modulus® ALIF System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2018-01-25
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2020-08-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-08-20
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2018-01-25
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-01-25
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2018-01-25
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
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
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-05-15
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2019-03-25
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2022-11-03
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2017-04-17
QLQ	Manual Instruments Designed For Use With Total Disc Replacement Devices	Orthopedic	Class 2	888.4515	2022-05-10
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
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2006-10-17
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
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2017-04-27
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2019-02-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-02-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-04-04
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2018-04-04
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2017-04-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2017-04-17
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2020-12-03
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
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2020-06-04
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2019-12-23
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2020-10-29
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2020-10-29
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2020-10-29
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2019-10-21
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2019-10-21
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2019-10-21
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	2007-02-26
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
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
PGN	Growing Rod System- Magnetic Actuation	Orthopedic	Class 2	888.3070	2017-07-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-10-15
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2020-10-15
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
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2020-04-02
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2006-11-02
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2020-12-04
MJO	Prosthesis, Intervertebral Disc	Unknown	Class 3	N/A	2022-05-10
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2020-12-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-12-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-12-30
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2020-12-30
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2018-01-25
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2006-11-02
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2023-03-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-03-20
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
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2018-04-09
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2018-04-09
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
PLR	Spinal Vertebral Body Replacement Device - Cervical	Orthopedic	Class 2	888.3060	2018-12-04
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2006-10-17
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2019-10-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-10-11
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
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
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2006-10-17
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2006-10-17
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2018-01-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-12-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-12-23
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2019-12-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-09-07
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2023-09-07
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2021-11-03
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
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-03-20
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-03-20
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-03-20
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
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
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-09-20
PGM	Growing Rod System	Orthopedic	Class 2	888.3070	2017-11-17
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2017-06-09
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-01-25
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2018-01-25
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2018-01-25
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2023-01-13
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-01-13
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-05-08
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2023-06-22
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-06-22
PGN	Growing Rod System- Magnetic Actuation	Orthopedic	Class 2	888.3070	2017-09-08
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	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
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2018-01-25
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2020-11-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2020-11-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2020-11-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-01-12
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-01-12
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-01-12
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2018-01-25
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	2020-07-13
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2021-03-02

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
2031966	NUVASIVE, INC.	SAN DIEGO, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05
K193541	Nu Vasive, Incorporated	NuVasive Cohere Thoracolumbar Interbody System	2020-03-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018	MicroPort Orthopedics Inc.	2	MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009144915. Last updated year: 2026. Please use registration number 3009144915 when referencing this establishment in official correspondence.