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Nu Vasive, Incorporated FDA Approvals

0 new drug approvals and 15 device clearances on file. This applicant is not matched to a listed company.

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A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
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 System510(k)Jul 11, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Jul 11, 2023
NuVasive Modulus ALIF System510(k)Jun 16, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 16, 2023
Rod Registration Frame510(k)May 5, 2023Neurology	Neurology	510(k)Substantially Equivalent (Special)	May 5, 2023
NuVasive Reline System510(k)Jan 11, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 11, 2023
NuVasive Cohere ALIF System Intervertebral Body Fusion Device510(k)Oct 21, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Oct 21, 2022
NuVasive Reline Cervical System510(k)Sep 9, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 9, 2022
NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System510(k)Jun 21, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 21, 2022
NuVasive Reline Cervical System510(k)Feb 23, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 23, 2022
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 Putty510(k)Dec 23, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 23, 2021
NuVasive Anterior Cervical Plate Systems510(k)Nov 3, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 3, 2021
NuVasive Pulse System510(k)Jul 29, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 29, 2021
NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System510(k)May 24, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 24, 2021
NuVasive MOD-EX XLIF Interbody System510(k)May 12, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 12, 2021
NuVasive Modulus ALIF System510(k)Mar 1, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Mar 1, 2021
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 System510(k)Jan 12, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 12, 2021

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