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FDA 510(k)

Navigation Enabled Instruments

K-Number: K183381 · 2019-05-17

ApplicantStryker
Decision Date2019-05-17
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Navigation Enabled Instruments is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2019-05-17 under approval number K183381. 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 Navigation Enabled Instruments?

Navigation Enabled Instruments is a medical device that received FDA 510(k) clearance on 2019-05-17. It is manufactured by Stryker. The 510(k) number is K183381.

When was Navigation Enabled Instruments approved by the FDA?

Navigation Enabled Instruments received FDA 510(k) clearance on 2019-05-17, under approval number K183381.

What company makes Navigation Enabled Instruments?

Navigation Enabled Instruments is manufactured by Stryker.

What is the FDA product code for Navigation Enabled Instruments?

The FDA product code for Navigation Enabled Instruments is 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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