Orthofix US, 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
Firebird SI Navigation System510(k)Oct 31, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Oct 31, 2025
OFIX MIS App510(k)Sep 26, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 26, 2023
3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System510(k)Feb 11, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 11, 2022
FORZA XP Expandable Spacer System510(k)Jan 5, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Jan 5, 2022