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FDA 510(k)

Stryker Universal Mesh

K-Number: K170773 · 2017-11-08

ApplicantStryker
Decision Date2017-11-08
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Stryker Universal Mesh is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2017-11-08 under approval number K170773. 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 Universal Mesh?

Stryker Universal Mesh is a medical device that received FDA 510(k) clearance on 2017-11-08. It is manufactured by Stryker. The 510(k) number is K170773.

When was Stryker Universal Mesh approved by the FDA?

Stryker Universal Mesh received FDA 510(k) clearance on 2017-11-08, under approval number K170773.

What company makes Stryker Universal Mesh?

Stryker Universal Mesh is manufactured by Stryker.

What is the FDA product code for Stryker Universal Mesh?

The FDA product code for Stryker Universal Mesh is JEY.

Related Clinical Trials

NCT05362370 Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness ACTIVE_NOT_RECRUITING NCT06941558 The UK ADAPTIS Study ACTIVE_NOT_RECRUITING NCT07245758 Facial iD Customized Mandible Reconstruction Plates COMPLETED NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED NCT07245810 Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up ACTIVE_NOT_RECRUITING NCT07221916 Stryker's Surgeon iD Mandible Reconstruction Plates: A Retrospective Post Market Follow Up COMPLETED

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Related Devices (Code: JEY)

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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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