FDA 510(k)

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

Numéro K : K222381 · 2023-04-27

Date de décision2023-04-27

Code produitHRS

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Autres dossiers indiquant Stryker GmbH en tant que demandeur

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 K250163T2 Alpha Femur Retrograde Nailing System K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System

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Dispositifs connexes (Code : HRS)

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Source officielle

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