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FDA 510(k)

Stryker MIS and Footed Attachments

K-Number: K191049 · 2019-06-18

Decision Date2019-06-18
Product CodeHBE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Stryker MIS and Footed Attachments is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2019-06-18 under 510(k) number K191049. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stryker MIS and Footed Attachments?

Stryker MIS and Footed Attachments is a medical device that received FDA 510(k) clearance on 2019-06-18. The listed applicant is Stryker Corporation. The 510(k) number is K191049.

When did Stryker MIS and Footed Attachments receive FDA 510(k) clearance?

Stryker MIS and Footed Attachments received FDA 510(k) clearance on 2019-06-18, under 510(k) number K191049.

Who is the listed applicant for Stryker MIS and Footed Attachments?

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 MIS and Footed Attachments?

The FDA product code for Stryker MIS and Footed Attachments is HBE.

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.

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Related Devices (Code: HBE)

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.