FDA 510(k)

Stryker Resorbable Fixation System

N.º K: K213777 · 2022-02-04

SolicitanteStryker Leibinger Micro Implants

Fecha de decisión2022-02-04

Código de productoJEY

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Stryker Resorbable Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Leibinger Micro Implants. It received FDA 510(k) clearance on 2022-02-04 under 510(k) number K213777. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Stryker Resorbable Fixation System?

Stryker Resorbable Fixation System is a medical device that received FDA 510(k) clearance on 2022-02-04. The listed applicant is Stryker Leibinger Micro Implants. The 510(k) number is K213777.

When did Stryker Resorbable Fixation System receive FDA 510(k) clearance?

Stryker Resorbable Fixation System received FDA 510(k) clearance on 2022-02-04, under 510(k) number K213777.

Who is the listed applicant for Stryker Resorbable Fixation System?

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

What is the FDA product code for Stryker Resorbable Fixation System?

The FDA product code for Stryker Resorbable Fixation System is JEY.

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Fuente oficial

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