Op.n Spine Navigation and Robotic Guidance— 510(k) K261113

Name: FDA 510(k) clearance K261113
Creator: U.S. Food and Drug Administration
Published: 2026-07-22

Substantially Equivalent

Ecential Robotics

FDA 510(k) clearance K261113 for Op.n Spine Navigation and Robotic Guidance, Substantially Equivalent on 2026-07-22. Applicant: Ecential Robotics. Device class: 2.

Clearance details

Applicant: Ecential Robotics
Product code: Code OLO
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2026-04-03
Decision date: 2026-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gieres, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLO

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K261024 — TMINI Miniature Robotic System2026-07-24
K262121 — Ion-L Navigated Instruments2026-07-24
K261852 — OTS Hip2026-07-01
K253921 — VERTICALE® Navigation Instruments2026-06-26
K260480 — VELYS Robotic-Assisted Solution2026-06-25

More clearances from Ecential Robotics

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K242914 — Op.n(TM) Navigation2025-03-07
K233228 — Spine Navigation and Robotic-Assistance Device2024-06-14
K231886 — SURGIVISIO Device2023-07-27
K221028 — SURGIVISIO Device2022-07-06
K220946 — SURGIVISIO Device2022-04-15

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.