Precision Spine, Inc. FDA Approvals

0 new drug approvals and 9 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
Dakota LP System510(k)Nov 24, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 24, 2025
Reform Pedicle Screw System510(k)Dec 17, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 17, 2024
S-COMP Reform® POCT Navigation Instruments510(k)May 25, 2023Neurology	Neurology	510(k)Substantially Equivalent (Special)	May 25, 2023
E-GPS Navigated Instruments510(k)Jul 14, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 14, 2022
Dakota ALIF System510(k)Apr 1, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 1, 2022
AccuFit Lateral 2-Hole Plate510(k)Mar 16, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 16, 2022
ShurFit Lumbar Interbody System510(k)Dec 8, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 8, 2021
Dakota ALIF Plate System510(k)Nov 4, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 4, 2021
NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System510(k)Jan 12, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 12, 2021