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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 a medical device manufactured by Stryker Leibinger GmbH & Co KG. It received FDA 510(k) clearance on 2016-10-12 under approval 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. It is manufactured by Stryker Leibinger GmbH & Co KG. The 510(k) number is K162341.

When was Stryker OrthoMap Precision Knee system approved by the FDA?

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

What company makes Stryker OrthoMap Precision Knee system?

Stryker OrthoMap Precision Knee system is manufactured by Stryker Leibinger GmbH & Co KG.

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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