S.M.A.I.O is one of 270 FDA 510(k) medical device manufacturers from France in the dataset, ranked by real submission volume.
S.M.A.I.O - FDA 510(k) Cleared Devices
Recent clearances: KHEIRON® Spinal Fixation System, including patient specific K-ROD, KBA3D (v2.4.0), KHEIRON® Spinal Fixation System, including patient specific K-ROD
13
Total
13
Cleared
0
Denied
S.M.A.I.O has 13 FDA 510(k) cleared orthopedic devices. Based in Saint-Priest, FR.
Latest FDA clearance: Sep 2026. Active since 2020.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by BioVera, Inc. and The OrthoMedix Group, Inc..
FDA 510(k) Regulatory Record - S.M.A.I.O
13 devices
Cleared
Sep 04, 2026
KHEIRON® Spinal Fixation System, including patient specific K-ROD
Orthopedic
25d
Cleared
Aug 17, 2026
KBA3D (v2.4.0)
Radiology
103d
Cleared
Jul 01, 2026
KHEIRON® Spinal Fixation System, including patient specific K-ROD
Orthopedic
215d
Cleared
Apr 03, 2026
KHEIRON® Spinal Fixation System, including patient specific K-ROD
Orthopedic
24d
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
May 30, 2023
KBA3D
Radiology
159d
Cleared
Jun 09, 2022
KHEIRON® Spinal Fixation System
Orthopedic
349d
Cleared
May 06, 2022
KEOPS Balance Analyzer 3D
Radiology
137d
Cleared
Aug 10, 2021
KHEIRON Spinal Fixation System
Orthopedic
96d