Nu Vasive, Incorporated
San Diego, CA, US
Nu Vasive, Incorporated appears in FDA device records in San Diego, CA. FDA records list 112 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 112
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 112FDA records hold 112 510(k) clearances for Nu Vasive, Incorporated between 2012 and 2023. The busiest year on record is 2017, with 22. The most recent is 2023, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 2 |
| 2013 | 3 |
| 2014 | 12 |
| 2015 | 16 |
| 2016 | 14 |
| 2017 | 22 |
| 2018 | 8 |
| 2019 | 10 |
| 2020 | 10 |
| 2021 | 7 |
| 2022 | 4 |
| 2023 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231735 | NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System | ODP | Substantially Equivalent | |
| K230894 | NuVasive Modulus ALIF System | OVD | Substantially Equivalent | |
| K230989 | Rod Registration Frame | OLO | Substantially Equivalent | |
| K223181 | NuVasive Reline System | NKB | Substantially Equivalent | |
| K221751 | NuVasive Cohere ALIF System Intervertebral Body Fusion Device | OVD | Substantially Equivalent | |
| K221388 | NuVasive Reline Cervical System | NKG | Substantially Equivalent | |
| K220478 | NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System | MAX | Substantially Equivalent | |
| K213654 | NuVasive Reline Cervical System | NKG | Substantially Equivalent | |
| K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty | MAX | Substantially Equivalent | |
| K212446 | NuVasive Anterior Cervical Plate Systems | KWQ | Substantially Equivalent | |
| K210574 | NuVasive Pulse System | OLO | Substantially Equivalent | |
| K210214 | NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System | MAX | Substantially Equivalent | |
| K210439 | NuVasive MOD-EX XLIF Interbody System | MAX | Substantially Equivalent | |
| K210271 | NuVasive Modulus ALIF System | OVD | Substantially Equivalent | |
| K203201 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF System | MAX | Substantially Equivalent | |
| K203253 | NuVasive ACP System | KWQ | Substantially Equivalent | |
| K200719 | NuVasive Navigation.S Instruments | OLO | Substantially Equivalent | |
| K201692 | NuVasive Modulus XLIF Interbody System | MAX | Substantially Equivalent | |
| K200953 | NuVasive® Cohere® Thoracolumbar Interbody System | MAX | Substantially Equivalent | |
| K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System | MAX | Substantially Equivalent | |
| K200956 | NuVasive Thoracolumbar Plates | KWQ | Substantially Equivalent | |
| K201078 | NuVasive® ACP System | KWQ | Substantially Equivalent | |
| K193541 | NuVasive Cohere Thoracolumbar Interbody System | MAX | Substantially Equivalent | |
| K193593 | NuVasive 3DP Interfixated ALIF System | OVD | Substantially Equivalent | |
| K193506 | NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System | MQP | Substantially Equivalent | |
| K192582 | NuVasive CoRoent Small Interlock System | OVE | Substantially Equivalent | |
| K191974 | NuVasive AttraX Putty | MQV | Substantially Equivalent | |
| K190636 | NuVasive® Reline® 4.5-5.0 System | NKB | Substantially Equivalent | |
| K192760 | NuVasive Modulus XLIF Interbody System | MAX | Substantially Equivalent | |
| K192435 | NuVasive NuvaLine | LLZ | Substantially Equivalent | |
| K191500 | NuVasive® ACP System | KWQ | Substantially Equivalent | |
| K191553 | NuVaisve® Reline® Cervical System | NKG | Substantially Equivalent | |
| K191169 | NuVasive® Camber Laminoplasty System | NQW | Substantially Equivalent | |
| K190418 | NuVasive® VersaTie® System | OWI | Substantially Equivalent | |
| K182974 | NuVasive Reline System | NKB | Substantially Equivalent | |
| K180498 | NuVasive Reline Fenestrated Screws, High V+ Bone Cement | PML | Substantially Equivalent | |
| K180550 | NuVasive Monolith Cervical Corpectomy System | PLR | Substantially Equivalent | |
| K181860 | NuVasive Cohere Thoracolumbar Interbody System | MAX | Substantially Equivalent | |
| K181386 | NuVasive Brigade Lateral System | OVD | Substantially Equivalent | |
| K180038 | NuVasive Pulse System | OLO | Substantially Equivalent | |
| K173892 | NuVasive® XLX Interbody System | MAX | Substantially Equivalent | |
| K180198 | NuVasive® VuePoint® II OCT System | NKG | Substantially Equivalent | |
| K173025 | NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP Expandable XLIF System | MAX | Substantially Equivalent | |
| K172623 | NuVasive Navigation Instruments | OLO | Substantially Equivalent | |
| K172676 | NuVasive® Modulus-C Interbody System | ODP | Substantially Equivalent | |
| K173153 | Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System | MAX | Substantially Equivalent | |
| K172497 | NuVasive AttraX Scaffold | MQV | Substantially Equivalent | |
| K173030 | Vertera Spine Cohere Cervical Interbody Fusion Device | ODP | Substantially Equivalent | |
| K173314 | LessRay System | OWB | Substantially Equivalent | |
| K172979 | NuVasive® Growth Rod Conversion Set | PGM | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KWQAppliance, Fixation, Spinal Intervertebral Body
- PMLBone Cement, Posterior Screw Augmentation
- OWIBone Fixation Cerclage, Sublaminar
- MQVFiller, Bone Void, Calcium Compound
- PGMGrowing Rod System
- OWBInterventional Fluoroscopic X-Ray System
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- PHMIntervertebral Fusion Device With Bone Graft, Thoracic
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- PDQNeurosurgical Nerve Locator
- OLOOrthopedic Stereotaxic Instrument
- NQWOrthosis, Spine, Plate, Laminoplasty, Metal
- NKGPosterior Cervical Screw System
- MQPSpinal Vertebral Body Replacement Device
- PLRSpinal Vertebral Body Replacement Device - Cervical
- PEKSpinous Process Plate
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- ETNStimulator, Nerve
- LLZSystem, Image Processing, Radiological
- NKBThoracolumbosacral Pedicle Screw System
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain