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FDA 510(k)

Stryker OrthoMap Precision Knee system

K-Number: K162341 · 2016-10-12

ApplicantStryker Leibinger GmbH & Co KG
Decision Date2016-10-12
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Stryker OrthoMap Precision Knee system is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Leibinger GmbH & Co KG. It received FDA 510(k) clearance on 2016-10-12 under 510(k) number K162341. 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 Stryker OrthoMap Precision Knee system?

Stryker OrthoMap Precision Knee system is a medical device that received FDA 510(k) clearance on 2016-10-12. The listed applicant is Stryker Leibinger GmbH & Co KG. The 510(k) number is K162341.

When did Stryker OrthoMap Precision Knee system receive FDA 510(k) clearance?

Stryker OrthoMap Precision Knee system received FDA 510(k) clearance on 2016-10-12, under 510(k) number K162341.

Who is the listed applicant for Stryker OrthoMap Precision Knee system?

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

What is the FDA product code for Stryker OrthoMap Precision Knee system?

The FDA product code for Stryker OrthoMap Precision Knee system 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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