S.M.A.I.O
S.M.A.I.O appears in FDA public data with 0 recalls, 13 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on September 4, 2026.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 13
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K262828 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | September 4, 2026 |
| K261500 | KBA3D (v2.4.0) | August 17, 2026 |
| K253802 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | July 1, 2026 |
| K260786 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | April 3, 2026 |
| K253990 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | January 7, 2026 |
| K253721 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | December 17, 2025 |
| K251804 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | July 8, 2025 |
| K232650 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | September 29, 2023 |
| K223841 | KBA3D | May 30, 2023 |
| K211981 | KHEIRON® Spinal Fixation System | June 9, 2022 |
| K213975 | KEOPS Balance Analyzer 3D | May 6, 2022 |
| K211414 | KHEIRON Spinal Fixation System | August 10, 2021 |
| K201659 | KHEIRON® Spinal Fixation System | October 5, 2020 |