FDA 510(k)

PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System

N.º K: K222381 · 2023-04-27

Fecha de decisión2023-04-27

Código de productoHRS

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker GmbH. It received FDA 510(k) clearance on 2023-04-27 under 510(k) number K222381. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System?

PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System is a medical device that received FDA 510(k) clearance on 2023-04-27. The listed applicant is Stryker GmbH. The 510(k) number is K222381.

When did PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System receive FDA 510(k) clearance?

PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System received FDA 510(k) clearance on 2023-04-27, under 510(k) number K222381.

Who is the listed applicant for PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System?

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

What is the FDA product code for PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System?

The FDA product code for PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System is HRS.

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Otros registros que enlistan a Stryker GmbH como solicitante

K261481Pangea Femur Reconstruction System K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System K253202Hoffmann LRF System K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System K250163Sistema de Clavo Retrogrado T2 Alpha Fémur K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System

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Fuente oficial

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