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FDA 510(k)

Stryker OrthoMap Versatile Hip System

K-Number: K162937 · 2017-02-23

Decision Date2017-02-23
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Stryker OrthoMap Versatile Hip System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2017-02-23 under 510(k) number K162937. 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 Versatile Hip System?

Stryker OrthoMap Versatile Hip System is a medical device that received FDA 510(k) clearance on 2017-02-23. The listed applicant is Stryker Corporation. The 510(k) number is K162937.

When did Stryker OrthoMap Versatile Hip System receive FDA 510(k) clearance?

Stryker OrthoMap Versatile Hip System received FDA 510(k) clearance on 2017-02-23, under 510(k) number K162937.

Who is the listed applicant for Stryker OrthoMap Versatile Hip System?

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

What is the FDA product code for Stryker OrthoMap Versatile Hip System?

The FDA product code for Stryker OrthoMap Versatile Hip System is OLO.

Other records listing Stryker Corporation as applicant

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.

View all 164 devices →

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.

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.