Kyocera Medical Technologies Inc. (KMTI) FDA Approvals

0 new drug approvals and 3 device clearances on file. Matched by name to KYOCF.

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
Varion Thoracolumbar Fixation System510(k)May 15, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 15, 2026
Skyway Anterior Cervical Plate System510(k)Apr 10, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Apr 10, 2025
Skyway Anterior Cervical Plate System510(k)Sep 12, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 12, 2023