Choice Spine, LLC FDA Approvals

0 new drug approvals and 6 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
ChoiceSpine Blackhawk Ti Cervical Spacer System510(k)Sep 14, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 14, 2023
ChoiceSpine TigerShark M, Modular Interbody System510(k)Sep 13, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 13, 2022
ChoiceSpine Navigation System510(k)Jul 6, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 6, 2022
Triton Sacroiliac Joint Fixation System510(k)Aug 31, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 31, 2021
ChoiceSpine Blackhawk Ti Cervical Spacer System510(k)May 10, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 10, 2021
ChoiceSpine Navigation System510(k)Jan 4, 2021Neurology	Neurology	510(k)Substantially Equivalent (Special)	Jan 4, 2021