Medical Device Manufacturer · US , San Diego , CA

Nu Vasive, Incorporated

112 submissions · 112 cleared · Since 2012
112
Total
112
Cleared
0
Denied

Nu Vasive, Incorporated — FDA 510(k) Submissions

Nu Vasive, Incorporated has submitted 112 FDA 510(k) premarket notifications since 2012, of which 112 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Intervertebral Fusion Device With Bone Graft, Lumbar, Intervertebral Fusion Device With Integrated Fixation, Lumbar, Thoracolumbosacral Pedicle Screw System, Intervertebral Fusion Device With Bone Graft, Cervical, Appliance, Fixation, Spinal Intervertebral Body . Use the specialty filter in the sidebar to narrow results.

112 devices
1–25 of 112
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
K231735 · ODP Intervertebral Fusion... · Orthopedic
Jul 2023 27d
NuVasive Modulus ALIF System
K230894 · OVD Intervertebral Fusion... · Orthopedic
Jun 2023 77d
Rod Registration Frame
K230989 · OLO Orthopedic Stereotaxic... · Orthopedic
May 2023 29d
NuVasive Reline System
K223181 · NKB Thoracolumbosacral... · Orthopedic
Jan 2023 92d
NuVasive Cohere ALIF System Intervertebral Body Fusion Device
K221751 · OVD Intervertebral Fusion... · Orthopedic
Oct 2022 127d
NuVasive Reline Cervical System
K221388 · NKG Posterior Cervical Screw... · Orthopedic
Sep 2022 119d
NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System
K220478 · MAX Intervertebral Fusion... · Orthopedic
Jun 2022 123d
NuVasive Reline Cervical System
K213654 · NKG Posterior Cervical Screw... · Orthopedic
Feb 2022 96d
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
K203714 · MAX Intervertebral Fusion... · Orthopedic
Dec 2021 367d
NuVasive Anterior Cervical Plate Systems
K212446 · KWQ Appliance, Fixation,... · Orthopedic
Nov 2021 90d
NuVasive Pulse System
K210574 · OLO Orthopedic Stereotaxic... · Orthopedic
Jul 2021 153d
NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System
K210214 · MAX Intervertebral Fusion... · Orthopedic
May 2021 117d
NuVasive MOD-EX XLIF Interbody System
K210439 · MAX Intervertebral Fusion... · Orthopedic
May 2021 89d
NuVasive Modulus ALIF System
K210271 · OVD Intervertebral Fusion... · Orthopedic
Mar 2021 28d
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
K203201 · MAX Intervertebral Fusion... · Orthopedic
Jan 2021 75d
NuVasive ACP System
K203253 · KWQ Appliance, Fixation,... · Orthopedic
Dec 2020 29d
NuVasive Navigation.S Instruments
K200719 · OLO Orthopedic Stereotaxic... · Orthopedic
Dec 2020 258d
NuVasive Modulus XLIF Interbody System
K201692 · MAX Intervertebral Fusion... · Orthopedic
Oct 2020 129d
NuVasive? Cohere? Thoracolumbar Interbody System
K200953 · MAX Intervertebral Fusion... · Orthopedic
Oct 2020 180d
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
K201820 · MAX Intervertebral Fusion... · Orthopedic
Sep 2020 86d
NuVasive Thoracolumbar Plates
K200956 · KWQ Appliance, Fixation,... · Orthopedic
May 2020 42d
NuVasive? ACP System
K201078 · KWQ Appliance, Fixation,... · Orthopedic
May 2020 28d
NuVasive Cohere Thoracolumbar Interbody System
K193541 · MAX Intervertebral Fusion... · Orthopedic
Mar 2020 101d
NuVasive 3DP Interfixated ALIF System
K193593 · OVD Intervertebral Fusion... · Orthopedic
Mar 2020 93d
NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System
K193506 · MQP Spinal Vertebral Body... · Orthopedic
Feb 2020 70d

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