BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NUVASIVE, INC.

    Reg #: 2031966 · FEI: 3002980729 · Expires 2026
    View on FDA
    Products
    60
    Proprietary Names
    199
    Establishment Types
    5
    Classifications
    60

    Registration Details

    Registration Name
    NUVASIVE, INC.
    Registration Number
    2031966
    FEI Number
    3002980729
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7475 Lusk Blvd
    City
    SAN DIEGO
    State
    CA
    ZIP
    92121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162138
    PMA Number
    P200022

    Owner / Operator

    Firm Name
    NUVASIVE, INC.
    Operator Number
    9036345
    Address
    2560 General Armistead Ave, VALLEY FORGE BUSINESS CENTER
    City
    Audubon
    State
    PA
    Postal Code
    19403
    Country
    US
    Correspondent
    Daniel S Paul

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Stimulator, Electrical, Evoked Response GWF
    Light, Surgical, Fiberoptic FST
    Spinal Vertebral Body Replacement Device MQP
    Extractor HWB
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthosis, Spinal Pedicle Fixation MNI
    Intervertebral Fusion Device With Bone Graft, Thoracic PHM
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Orthopedic Stereotaxic Instrument OLO
    Awl HWJ
    Filler, Bone Void, Calcium Compound MQV
    Spinous Process Plate PEK
    Wrench HXC
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Bit, Drill HTW
    Electromyograph, Diagnostic IKN
    Stimulator, Nerve ETN
    Neurological Stereotaxic Instrument HAW
    Interventional Fluoroscopic X-Ray System OWB
    Neurosurgical Nerve Locator PDQ
    System, Image Processing, Radiological LLZ
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Cable, Electrode IKD
    Posterior Cervical Screw System NKG
    Stretcher, Wheeled, Powered INK
    Rod, Fixation, Intramedullary And Accessories HSB
    Spinal Vertebral Body Replacement Device - Cervical PLR
    Gauge, Depth HTJ
    Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) MBP
    Tube, Tracheal (W/Wo Connector) BTR
    Cuff, Tracheal Tube, Inflatable BSK
    Driver, Prosthesis HWR
    Mallet HXL
    Retractor GAD
    Growing Rod System PGM
    Stimulator, Nerve, Ac-Powered BXM
    Bone Fixation Cerclage, Sublaminar OWI
    Prosthesis, Intervertebral Disc MJO
    Orthosis, Spine, Plate, Laminoplasty, Metal NQW
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Bone Cement, Posterior Screw Augmentation PML
    System, Facet Screw Spinal Device MRW
    Instrument, Compression HWN
    System, X-Ray, Film Marking, Radiographic JAC
    Apparatus, Traction, Non-Powered HST
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Mesh, Surgical, Polymeric FTL
    Template HWT
    Accessories, Arthroscopic NBH
    Screwdriver HXX
    Tape, Measuring, Rulers And Calipers FTY
    Impactor HWA
    Orthopedic Manual Surgical Instrument LXH
    Manual Instruments Designed For Use With Total Disc Replacement Devices QLQ

    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® 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® 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 GAUGE, DEPTH Affix II Spinous Process Plate System NuVasive Propel DBM Putty and Gel Plus NuVasive ET TUBE 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 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 NuVasive® Lumbar Interbody Implants XLIF Stimulating Electrode SpheRx Spinal System Vertera Spine Cohere Cervical Interbody Fusion Device NUVASIVE COROENT L & XL SYSTEMS XLP II Lateral Plate NUVASIVE COROENT SYSTEM 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® 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 AttraX Scaffold NuVasive® Anterior Cervical Plate Systems PIN TRACTION NuVasive PCM Cervical Disc NuVasive® CoRoent® Thoracolumbar System NuVasive NV EMG Endotracheal Tube NuVasive CoRoent 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 Cohere Cervical Interbody System CoRoent Small Interbody 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® MLX® - Medial Lateral Expandable Lumbar Interbody System, NuVasive® AP Expandable XLIF System NuVasive RELINE System NuVasive CoRoent Small Interbody System NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System NV JJB SYSTEMS NuVasive CoRoent Thoracolumbar System Gradient Plus System NuVasive® LessRay® with Enhanced Tracking Stimulation/Dissection Instruments Brigade Hyperlordotic NuVasive Modulus XLIF Interbody System NuVasive CoRoent Small Interlock II System NuVasive® Modulus-C Interbody System Template NuVasive StruXure Spinal System NuVasive ALIF Interfixated System Coalesce™ Lumbar Interbody Fusion System MANUAL SURGICAL INSTRUMENTS Screwdriver Tape, Measuring, Rulers and Calipers AttraX Granules Helix Anterior Cervical Plating System NuVasive Modulus ALIF System NuVasive PEEK Corpectomy Railed IMPACTOR NuVasive® Monolith Corpectomy System Leverage Laminoplasty System NuVasive® NuvaLine® NuVasive Affix IIS Spinous Process Plate System CoRoent Small Interlock PreCept Spinal System NuVasive® Monolith™ Cervical Corpectomy System NuVasive® Modulus® XLIF Interbody System AttraX Putty NuVasive XLIF Decade Lateral Plate System Supplemental Instrument Trays NuVasive® X-Core® Mini Cervical Expandable VBR System LessRay® System NuVasive MAS PlIF Fixation System NuVasive Surgical Mesh NuVasive VersaTie System Helix Revolution ACP System Radian Facet Screw System CoRoent Ti-C System Halo Anterior Lumbar Plate System NuVaisve® Reline® Cervical System General Instruments ARCHON-R ACP Simplify® Disc Inserter FP

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Device in the United States for Export Only Repack or Relabel Medical Device