Ortler Global Tibbi Gerecler Anonim Sirketi 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
FRAXION Spinal Fixation System510(k)Sep 17, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 17, 2026
FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)510(k)Aug 28, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 28, 2026