SpineCraft FDA Approvals

0 new drug approvals and 2 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
ORIO-3D Cage System510(k)Apr 16, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 16, 2026
ANTERIS Thoracolumbar Plate System510(k)Mar 4, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 4, 2026