Dynamis Robotic Surgical System— 510(k) K260369

Name: FDA 510(k) clearance K260369
Creator: U.S. Food and Drug Administration
Published: 2026-06-20

Substantially Equivalent

LEM Surgical AG

FDA 510(k) clearance K260369 for Dynamis Robotic Surgical System, Substantially Equivalent on 2026-06-20. Applicant: LEM Surgical AG. Device class: 2.

Summary

LEM Surgical's Dynamis Robotic Surgical System is filed under OLO, orthopedic stereotaxic instruments. The record doesn't say which procedures or components the clearance covers.

Class II, 21 CFR 882.4560. The Orthopedic review panel handled it as a Traditional 510(k), though the record lists Neurology as the classification panel.

LEM Surgical filed from Berne, Switzerland. Review took 135 calendar days (February 5 to June 20, 2026).

Clearance details

Applicant: LEM Surgical AG
Product code: Product code OLO
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2026-02-05
Decision date: 2026-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berne, CH

Download summary PDF View on FDA.gov ↗

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More clearances from LEM Surgical AG

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K243326 — Dynamis Robotic Surgical System2025-04-23

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.