Medical Device Manufacturer · FR , Saint-Priest

S.M.A.I.O - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2020

9

Total

9

Cleared

0

Denied

FDA 510(k) cleared devices by S.M.A.I.O Orthopedic ✕

7 devices

1-7 of 7

Cleared Jan 07, 2026

KHEIRON® Spinal Fixation System, including patient specific K-ROD

Orthopedic · 26d

Cleared Dec 17, 2025

KHEIRON® Spinal Fixation System, including patient specific K-ROD

Orthopedic · 23d

Cleared Jul 08, 2025

KHEIRON® Spinal Fixation System, including patient specific K-ROD

Orthopedic · 26d

Cleared Sep 29, 2023

KHEIRON® Spinal Fixation System, including patient specific K-ROD

Orthopedic · 29d

Cleared Jun 09, 2022

KHEIRON® Spinal Fixation System

Orthopedic · 349d

Cleared Aug 10, 2021

KHEIRON Spinal Fixation System

Orthopedic · 96d

Cleared Oct 05, 2020

KHEIRON® Spinal Fixation System

Orthopedic · 109d