Orthofix Srl FDA Approvals

0 new drug approvals and 11 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
FITBONE® TRANSPORT AND LENGTHENING SYSTEM510(k)May 19, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 19, 2026
Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA510(k)May 8, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 8, 2026
FitboneTM Trochanteric510(k)Apr 10, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 10, 2025
OrthoNext Platform System510(k)Dec 19, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 19, 2024
TrueLok Elevate510(k)Dec 3, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 3, 2024
Fitbone Trochanteric510(k)Jun 18, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 18, 2024
RODEO Telescopic Nail510(k)May 3, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 3, 2024
FITBONE® Transport and Lengthening System510(k)Mar 22, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 22, 2024
JuniOrtho Plating System510(k)Jan 18, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 18, 2022
TrueLok Evo510(k)Nov 5, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 5, 2021
SOLE Medial Column Fusion Plate510(k)Apr 20, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 20, 2021