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Corelink, LLC FDA Approvals

0 new drug approvals and 12 device clearances on file. This applicant is not matched to a listed company.

Newest first

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
F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System510(k)Dec 8, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 8, 2023
CoreLink Robotic Navigation Instruments510(k)Oct 27, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Oct 27, 2023
CoreLink Navigation Instruments510(k)Aug 16, 2023Neurology	Neurology	510(k)Substantially Equivalent (Special)	Aug 16, 2023
F3D Interbody System510(k)Jun 6, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 6, 2023
CoreLink Navigation Instruments510(k)May 2, 2023Neurology	Neurology	510(k)Substantially Equivalent (Special)	May 2, 2023
Entasis 3D Dual-Lead Sacroiliac Implant System510(k)Mar 21, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 21, 2023
NextGen Pedicle Screw System510(k)Aug 9, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 9, 2022
CoreLink Navigation Instruments510(k)Jun 1, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jun 1, 2022
F3D-C2 Cervical Stand-Alone System510(k)Feb 4, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 4, 2022
CoreLink Navigation Instruments510(k)Jan 19, 2022Neurology	Neurology	510(k)Substantially Equivalent (Special)	Jan 19, 2022
CoreLink Navigation Instruments510(k)Oct 13, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Oct 13, 2021
CoreLink Midline Fixation System510(k)Apr 15, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 15, 2021

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