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FDA 510(k)

SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set

K-Number: K191943 · 2019-10-18

ApplicantMedos International SARL
Decision Date2019-10-18
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2019-10-18 under 510(k) number K191943. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set?

SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set is a medical device that received FDA 510(k) clearance on 2019-10-18. The listed applicant is Medos International SARL. The 510(k) number is K191943.

When did SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set receive FDA 510(k) clearance?

SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set received FDA 510(k) clearance on 2019-10-18, under 510(k) number K191943.

Who is the listed applicant for SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set?

The FDA 510(k) record lists Medos International SARL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set?

The FDA product code for SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set is OLO.

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Other records listing Medos International SARL as applicant

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Related Devices (Code: OLO)

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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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