SPINEART Navigation Instrument System— 510(k) K261205

Name: FDA 510(k) clearance K261205
Creator: U.S. Food and Drug Administration
Published: 2026-07-29

Substantially Equivalent

Spineart SA

FDA 510(k) clearance K261205 for SPINEART Navigation Instrument System, Substantially Equivalent on 2026-07-29. Applicant: Spineart SA. Device class: 2.

Clearance details

Applicant: Spineart SA
Product code: Code OLO
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2026-04-13
Decision date: 2026-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plan-Les-Ouates, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLO

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K261410 — Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))2026-07-30
K261024 — TMINI Miniature Robotic System2026-07-24
K262121 — Ion-L Navigated Instruments2026-07-24
K261113 — Op.n Spine Navigation and Robotic Guidance2026-07-22
K261852 — OTS Hip2026-07-01

More clearances from Spineart SA

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K253966 — PERLA® TL Posterior Thoraco-lumbar Fixation System2026-05-01
K254158 — SPINEART Navigation Instrument System2026-04-09
K242933 — SPINEART Navigation Instrument System2025-06-18
K242890 — SPINEART Navigation Instrument System2025-03-07
K242589 — Scarlet® AL-T2024-10-23

Adverse events under product code OLO

product code OLO

Death: 11
Injury: 2,799
Malfunction: 11,105
Other: 1
Total: 13,916

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.