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FDA 510(k)

ROSA SURGICAL DEVICE, MODEL ROSA 1.1

K-Number: K092239 · 2009-11-17

ApplicantMedtech S.A
Decision Date2009-11-17
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ROSA SURGICAL DEVICE, MODEL ROSA 1.1 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 2009-11-17 under 510(k) number K092239. 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, MODEL ROSA 1.1?

ROSA SURGICAL DEVICE, MODEL ROSA 1.1 is a medical device that received FDA 510(k) clearance on 2009-11-17. The listed applicant is Medtech S.A. The 510(k) number is K092239.

When did ROSA SURGICAL DEVICE, MODEL ROSA 1.1 receive FDA 510(k) clearance?

ROSA SURGICAL DEVICE, MODEL ROSA 1.1 received FDA 510(k) clearance on 2009-11-17, under 510(k) number K092239.

Who is the listed applicant for ROSA SURGICAL DEVICE, MODEL ROSA 1.1?

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 SURGICAL DEVICE, MODEL ROSA 1.1?

The FDA product code for ROSA SURGICAL DEVICE, MODEL ROSA 1.1 is HAW.

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Related Devices (Code: HAW)

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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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