Medical Device Manufacturer · FR , Saint-Priest

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

9 submissions · 9 cleared · Since 2020

Total

Cleared

Denied

S.M.A.I.O has 9 FDA 510(k) cleared medical devices. Based in Saint-Priest, FR.

Latest FDA clearance: Jan 2026. Active since 2020. Primary specialty: Orthopedic.

Browse the FDA 510(k) cleared devices submitted by S.M.A.I.O Filter by specialty or product code using the sidebar.

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

9 devices

1-9 of 9

Cleared Jan 07, 2026

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

K253990 · NKB

Orthopedic · 26d

Cleared Dec 17, 2025

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

K253721 · NKB

Orthopedic · 23d

Cleared Jul 08, 2025

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

K251804 · NKB

Orthopedic · 26d

Cleared Sep 29, 2023

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

KHEIRON® Spinal Fixation System

K211981 · NKB

Orthopedic · 349d

Cleared May 06, 2022

KEOPS Balance Analyzer 3D

K213975 · LLZ

Radiology · 137d

Cleared Aug 10, 2021

KHEIRON Spinal Fixation System

K211414 · NKB

Orthopedic · 96d

Cleared Oct 05, 2020

KHEIRON® Spinal Fixation System

K201659 · NKB

Orthopedic · 109d

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

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

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