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FDA 510(k)

Dynamis Robotic Surgical System

K-Number: K260369 · 2026-06-20

ApplicantLEM Surgical AG
Decision Date2026-06-20
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Dynamis Robotic Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is LEM Surgical AG. It received FDA 510(k) clearance on 2026-06-20 under 510(k) number K260369. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dynamis Robotic Surgical System?

Dynamis Robotic Surgical System is a medical device that received FDA 510(k) clearance on 2026-06-20. The listed applicant is LEM Surgical AG. The 510(k) number is K260369.

When did Dynamis Robotic Surgical System receive FDA 510(k) clearance?

Dynamis Robotic Surgical System received FDA 510(k) clearance on 2026-06-20, under 510(k) number K260369.

Who is the listed applicant for Dynamis Robotic Surgical System?

The FDA 510(k) record lists LEM Surgical AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dynamis Robotic Surgical System?

The FDA product code for Dynamis Robotic Surgical System is OLO.

Other records listing LEM Surgical AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243326Dynamis Robotic Surgical System

Related Devices (Code: OLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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