FDA Registration
Active
🇺🇸 United States
NUVASIVE, INC.
Reg #: 3009144915
·
FEI: 3009144915
·
Expires 2026
Products
42
Proprietary Names
95
Establishment Types
1
Classifications
42
Registration Details
- Registration Name
- NUVASIVE, INC.
- Registration Number
- 3009144915
- FEI Number
- 3009144915
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- City View Plaza 1 Suites 116 & 117, #48 Rd 165 Km 1.2
- City
- Guaynabo
- State
- PR
- ZIP
- 00968
- Country
- US
Regulatory Submissions
- 510(k) Number
- K172123
- 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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2017-11-17 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2017-11-17 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2017-11-17 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2018-01-25 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2020-08-20 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2020-08-20 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2018-01-25 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2018-01-25 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2018-01-25 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2018-12-04 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2018-12-04 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2018-12-04 |
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2019-03-25 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2017-04-17 |
| Manual Instruments Designed For Use With Total Disc Replacement Devices | QLQ | Class 2 | Orthopedic | No | 2022-05-10 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2021-09-03 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2021-09-03 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2021-09-03 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2021-09-03 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2021-09-03 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2021-09-03 |
| Light, Surgical, Fiberoptic | FST | Class 2 | General, Plastic Surgery | No | 2006-10-17 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2020-06-04 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2019-12-23 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2007-02-26 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2022-05-10 |
| Growing Rod System- Magnetic Actuation | PGN | Class 2 | Orthopedic | No | 2017-07-20 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2023-07-12 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2006-11-02 |
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2022-05-10 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2020-12-30 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2020-12-30 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2006-11-02 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2018-12-04 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2006-10-17 |
| Growing Rod System | PGM | Class 2 | Orthopedic | No | 2017-11-17 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2006-10-17 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2019-12-23 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2006-10-17 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2006-10-17 |
| Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | MBP | Class 2 | Orthopedic | No | 2018-10-17 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2019-09-20 |
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
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
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® Growth Rod Conversion Set
NuVasive CoRoent Small Interlock II System
NuVasive® LessRay® with Enhanced Tracking
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
NuVasive CoRoent Ti-C System
NuVasive® Modulus TLIF Interbody System
NuVaisve® Reline® Cervical System
Precice Bone Transport
MAGEC Spinal Bracing and Distraction System
NuVasive Triad Facet Screw System
Vertera Spine Cohere Cervical Interbody Fusion Device
NuVasive® NuvaLine®
NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System
PRECICE UNYTE CoCr System
Precice Screws
NuVasive® TLX Interbody System
ERC 3P
Armada Spinal Fixation system
NuVasive AttraX Scaffold
NuVasive® XLX Interbody System
NuVasive Propel DBM Putty and Gel Plus
Bendini Cloud Application
NuVasive® Camber Laminoplasty System
PRECICE IMLL Bone Transport
PRECICE UNYTE Bone Transport
NuVasive® AttraX® Putty
Establishment Types
Manufacture Medical Device