FDA 510(k)

ARVIS® Shoulder

K-Number: K240062 · 2024-04-29

Decision Date2024-04-29

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ARVIS® Shoulder is a medical device manufactured by Insight Medical Systems, Inc.. It received FDA 510(k) clearance on 2024-04-29 under approval number K240062. 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 ARVIS® Shoulder?

ARVIS® Shoulder is a medical device that received FDA 510(k) clearance on 2024-04-29. It is manufactured by Insight Medical Systems, Inc.. The 510(k) number is K240062.

When was ARVIS® Shoulder approved by the FDA?

ARVIS® Shoulder received FDA 510(k) clearance on 2024-04-29, under approval number K240062.

What company makes ARVIS® Shoulder?

ARVIS® Shoulder is manufactured by Insight Medical Systems, Inc..

What is the FDA product code for ARVIS® Shoulder?

The FDA product code for ARVIS® Shoulder is OLO.

Other Devices by Insight Medical Systems, Inc.

K203115ARVIS Surgical Navigation System

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Official Source

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