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S.M.A.I.O

Saint-Priest, FR · 11 510(k) clearances

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Total clearances
11
2020-10-05 → 2026-07-01
Last 12 months
4
Product codes
2
Most recent
2026-07-01
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NKB Thoracolumbosacral Pedicle Screw System Class II Orthopedic 9 2026-07-01
LLZ System, Image Processing, Radiological Class II Radiology 2 2023-05-30
Filings

All 510(k) clearances (11)

Date K-number Device Code Class Specialty
2026-07-01 K253802 KHEIRON® Spinal Fixation System, including patient specific K-ROD NKB Class II Orthopedic
2026-04-03 K260786 KHEIRON® Spinal Fixation System, including patient specific K-ROD NKB Class II Orthopedic
2026-01-07 K253990 KHEIRON® Spinal Fixation System, including patient specific K-ROD NKB Class II Orthopedic
2025-12-17 K253721 KHEIRON® Spinal Fixation System, including patient specific K-ROD NKB Class II Orthopedic
2025-07-08 K251804 KHEIRON® Spinal Fixation System, including patient specific K-ROD NKB Class II Orthopedic
2023-09-29 K232650 KHEIRON® Spinal Fixation System, including patient specific K-ROD NKB Class II Orthopedic
2023-05-30 K223841 KBA3D LLZ Class II Radiology
2022-06-09 K211981 KHEIRON® Spinal Fixation System NKB Class II Orthopedic
2022-05-06 K213975 KEOPS Balance Analyzer 3D LLZ Class II Radiology
2021-08-10 K211414 KHEIRON Spinal Fixation System NKB Class II Orthopedic
2020-10-05 K201659 KHEIRON® Spinal Fixation System NKB Class II Orthopedic
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence