FDA 510(k)

ROSA BRAIN (v3.0.0.5)

K-Number: K172444 · 2018-03-28

Decision Date2018-03-28

Product CodeHAW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ROSA BRAIN (v3.0.0.5) is a medical device manufactured by Medtech S.A. It received FDA 510(k) clearance on 2018-03-28 under approval number K172444. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROSA BRAIN (v3.0.0.5)?

ROSA BRAIN (v3.0.0.5) is a medical device that received FDA 510(k) clearance on 2018-03-28. It is manufactured by Medtech S.A. The 510(k) number is K172444.

When was ROSA BRAIN (v3.0.0.5) approved by the FDA?

ROSA BRAIN (v3.0.0.5) received FDA 510(k) clearance on 2018-03-28, under approval number K172444.

What company makes ROSA BRAIN (v3.0.0.5)?

ROSA BRAIN (v3.0.0.5) is manufactured by Medtech S.A.

What is the FDA product code for ROSA BRAIN (v3.0.0.5)?

The FDA product code for ROSA BRAIN (v3.0.0.5) is HAW.

Other Devices by Medtech S.A

K151511ROSA Spine K192173ROSA ONE Spine application K182848ROSA ONE Spine application K182417ROSA ONE Brain Application K200511ROSA ONE Brain application

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K162604Cranial Reducing TubesMedtronic Navigation, Inc. K160811CRW STEREOTACTIC SYSTEMIntegra LifeSciences Corporation K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. K152764EXACTECH GPSBlue Ortho K160523BrightMatter Guide with BrightMatter PointerSynaptive Medical, Inc. K151156Fiagon Navigation SystemFiagon GmbH

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.