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FDA 510(k)

Stryker Customized Mandible Recon Plate Kit

K-Number: K193136 · 2020-03-26

ApplicantStryker
Decision Date2020-03-26
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Stryker Customized Mandible Recon Plate Kit is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2020-03-26 under approval number K193136. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stryker Customized Mandible Recon Plate Kit?

Stryker Customized Mandible Recon Plate Kit is a medical device that received FDA 510(k) clearance on 2020-03-26. It is manufactured by Stryker. The 510(k) number is K193136.

When was Stryker Customized Mandible Recon Plate Kit approved by the FDA?

Stryker Customized Mandible Recon Plate Kit received FDA 510(k) clearance on 2020-03-26, under approval number K193136.

What company makes Stryker Customized Mandible Recon Plate Kit?

Stryker Customized Mandible Recon Plate Kit is manufactured by Stryker.

What is the FDA product code for Stryker Customized Mandible Recon Plate Kit?

The FDA product code for Stryker Customized Mandible Recon Plate Kit is JEY.

Related Clinical Trials

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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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