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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 a medical device manufactured by Stryker Corporation. It received FDA 510(k) clearance on 2019-06-18 under approval 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. It is manufactured by Stryker Corporation. The 510(k) number is K191049.

When was Stryker MIS and Footed Attachments approved by the FDA?

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

What company makes Stryker MIS and Footed Attachments?

Stryker MIS and Footed Attachments is manufactured by Stryker Corporation.

What is the FDA product code for Stryker MIS and Footed Attachments?

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

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Related Devices (Code: HBE)

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.