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S.M.A.I.O FDA Approvals
0 new drug approvals and 12 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 |
|---|
| KHEIRON® Spinal Fixation System, including patient specific K-ROD510(k)Sep 4, 2026Orthopedic |
| KBA3D (v2.4.0)510(k)Aug 17, 2026Radiology |
| KHEIRON® Spinal Fixation System, including patient specific K-ROD510(k)Jul 1, 2026Orthopedic |
| KHEIRON® Spinal Fixation System, including patient specific K-ROD510(k)Apr 3, 2026Orthopedic |
| KHEIRON® Spinal Fixation System, including patient specific K-ROD510(k)Jan 7, 2026Orthopedic |
| KHEIRON® Spinal Fixation System, including patient specific K-ROD510(k)Dec 17, 2025Orthopedic |
| KHEIRON® Spinal Fixation System, including patient specific K-ROD510(k)Jul 8, 2025Orthopedic |
| KHEIRON® Spinal Fixation System, including patient specific K-ROD510(k)Sep 29, 2023Orthopedic |
| KBA3D510(k)May 30, 2023Radiology |
| KHEIRON® Spinal Fixation System510(k)Jun 9, 2022Orthopedic |
| KEOPS Balance Analyzer 3D510(k)May 6, 2022Radiology |
| KHEIRON Spinal Fixation System510(k)Aug 10, 2021Orthopedic |