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FDA 510(k)

ARVIS® Shoulder

K-Number: K240062 · 2024-04-29

ApplicantInsight Medical Systems, Inc.
Decision Date2024-04-29
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ARVIS® Shoulder is the device name listed in this FDA 510(k) record. The listed applicant is Insight Medical Systems, Inc.. It received FDA 510(k) clearance on 2024-04-29 under 510(k) 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. The listed applicant is Insight Medical Systems, Inc.. The 510(k) number is K240062.

When did ARVIS® Shoulder receive FDA 510(k) clearance?

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

Who is the listed applicant for ARVIS® Shoulder?

The FDA 510(k) record lists Insight Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARVIS® Shoulder?

The FDA product code for ARVIS® Shoulder is OLO.

Other records listing Insight Medical Systems, Inc. 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.

K203115ARVIS Surgical Navigation 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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