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FDA 510(k)

ROSA BRAIN (v3.0.0.5)

K-Number: K172444 · 2018-03-28

ApplicantMedtech S.A
Decision Date2018-03-28
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ROSA BRAIN (v3.0.0.5) is the device name listed in this FDA 510(k) record. The listed applicant is Medtech S.A. It received FDA 510(k) clearance on 2018-03-28 under 510(k) 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. The listed applicant is Medtech S.A. The 510(k) number is K172444.

When did ROSA BRAIN (v3.0.0.5) receive FDA 510(k) clearance?

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

Who is the listed applicant for ROSA BRAIN (v3.0.0.5)?

The FDA 510(k) record lists Medtech S.A as the applicant. This does not by itself establish the device manufacturer.

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 records listing Medtech S.A 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.

K200511ROSA ONE Brain applicationK192173ROSA ONE Spine applicationK182848ROSA ONE Spine applicationK182417ROSA ONE Brain ApplicationK151511ROSA Spine

Related Devices (Code: HAW)

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.

K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical PartnersK250893Ball Joint Guide Array (66295)Bayer Medical Care, Inc.

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.

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