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FDA 510(k)

Stryker Facial iD Plating System

K-Number: K182305 · 2019-01-07

ApplicantStryker
Decision Date2019-01-07
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Stryker Facial iD Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2019-01-07 under 510(k) number K182305. 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 Facial iD Plating System?

Stryker Facial iD Plating System is a medical device that received FDA 510(k) clearance on 2019-01-07. The listed applicant is Stryker. The 510(k) number is K182305.

When did Stryker Facial iD Plating System receive FDA 510(k) clearance?

Stryker Facial iD Plating System received FDA 510(k) clearance on 2019-01-07, under 510(k) number K182305.

Who is the listed applicant for Stryker Facial iD Plating System?

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

What is the FDA product code for Stryker Facial iD Plating System?

The FDA product code for Stryker Facial iD Plating System is JEY.

Related Clinical Trials

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NCT07245758Facial iD Customized Mandible Reconstruction PlatesCOMPLETEDNCT07245810Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow UpACTIVE_NOT_RECRUITING

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Related Devices (Code: JEY)

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.

K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.K252246Leforte MMF SystemJeil Medical CorporationK253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty) , Ltd.K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OYK241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.K240651MRI UniversalStryker Leibinger GmbH & Co KG

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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