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FDA 510(k)

Styrker OrthoMap Express Knee System

K-Number: K153240 · 2016-07-07

ApplicantStryker Corporate
Decision Date2016-07-07
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Styrker OrthoMap Express Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporate. It received FDA 510(k) clearance on 2016-07-07 under 510(k) number K153240. 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 Styrker OrthoMap Express Knee System?

Styrker OrthoMap Express Knee System is a medical device that received FDA 510(k) clearance on 2016-07-07. The listed applicant is Stryker Corporate. The 510(k) number is K153240.

When did Styrker OrthoMap Express Knee System receive FDA 510(k) clearance?

Styrker OrthoMap Express Knee System received FDA 510(k) clearance on 2016-07-07, under 510(k) number K153240.

Who is the listed applicant for Styrker OrthoMap Express Knee System?

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

What is the FDA product code for Styrker OrthoMap Express Knee System?

The FDA product code for Styrker OrthoMap Express Knee System is OLO.

Related Devices (Code: OLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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