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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 the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2019-05-17 under 510(k) 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. The listed applicant is Stryker. The 510(k) number is K183381.

When did Navigation Enabled Instruments receive FDA 510(k) clearance?

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

Who is the listed applicant for Navigation Enabled Instruments?

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

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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