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FDA 510(k)

ROSA SURGICAL DEVICE

K-Number: K101791 · 2010-09-23

ApplicantMedtech S.A.S
Decision Date2010-09-23
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ROSA SURGICAL DEVICE 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 2010-09-23 under 510(k) number K101791. 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 SURGICAL DEVICE?

ROSA SURGICAL DEVICE is a medical device that received FDA 510(k) clearance on 2010-09-23. The listed applicant is Medtech S.A.S. The 510(k) number is K101791.

When did ROSA SURGICAL DEVICE receive FDA 510(k) clearance?

ROSA SURGICAL DEVICE received FDA 510(k) clearance on 2010-09-23, under 510(k) number K101791.

Who is the listed applicant for ROSA SURGICAL DEVICE?

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 SURGICAL DEVICE?

The FDA product code for ROSA SURGICAL DEVICE is HAW.

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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.

K231103ROSA ONE Brain ApplicationK214065ROSA 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.

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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.

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