Spinecraft, LLC FDA Approvals

0 new drug approvals and 4 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
ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System510(k)Jul 20, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 20, 2023
ASTRA Spine System510(k)Dec 22, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 22, 2022
ORIO-Ti Intervertebral Body Fusion Cage System510(k)Sep 30, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 30, 2021
ASTRA Spine System510(k)Jun 3, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Jun 3, 2021