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FDA 510(k)

ROSA ONE Brain Application

K-Number: K231103 · 2023-07-20

ApplicantMedtech S.A.S
Decision Date2023-07-20
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ROSA ONE Brain Application is the device name listed in this FDA 510(k) record. The listed applicant is Medtech S.A.S. It received FDA 510(k) clearance on 2023-07-20 under 510(k) number K231103. 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 ONE Brain Application?

ROSA ONE Brain Application is a medical device that received FDA 510(k) clearance on 2023-07-20. The listed applicant is Medtech S.A.S. The 510(k) number is K231103.

When did ROSA ONE Brain Application receive FDA 510(k) clearance?

ROSA ONE Brain Application received FDA 510(k) clearance on 2023-07-20, under 510(k) number K231103.

Who is the listed applicant for ROSA ONE Brain Application?

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

What is the FDA product code for ROSA ONE Brain Application?

The FDA product code for ROSA ONE Brain Application is HAW.

Other records listing Medtech S.A.S 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.

K214065ROSA ONE Brain application

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

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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