Chrysalis Intelligence · Sponsors · S.M.A.I.O

S.M.A.I.O

Saint-Priest, FR · 13 510(k) clearances

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Total clearances
13
2020-10-05 → 2026-09-04
Last 12 months
6
Product codes
2
Most recent
2026-09-04
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 10 2026-09-04
LLZ System, Image Processing, Radiological Class II Radiology 3 2026-08-17
Filings

All 510(k) clearances (13)

Date K-number Device Code Class Specialty
2026-09-04 K262828 KHEIRON® Spinal Fixation System, including patient specific K-ROD NKB Class II Orthopedic
2026-08-17 K261500 KBA3D (v2.4.0) LLZ Class II Radiology
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 2026-09-15 10:42 · Last ingest 2026-09-15T14:41:04.075193 · Pipeline: Chrysalis Intelligence