FDA 510(k)

Catalyst EA Convertible Stemmed Shoulder

N.º K: K222317 · 2022-11-10

Fecha de decisión2022-11-10

Código de productoKWS

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Catalyst EA Convertible Stemmed Shoulder is the device name listed in this FDA 510(k) record. The listed applicant is Catalyst Orthoscience, Inc.. It received FDA 510(k) clearance on 2022-11-10 under 510(k) number K222317. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Catalyst EA Convertible Stemmed Shoulder?

Catalyst EA Convertible Stemmed Shoulder is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Catalyst Orthoscience, Inc.. The 510(k) number is K222317.

When did Catalyst EA Convertible Stemmed Shoulder receive FDA 510(k) clearance?

Catalyst EA Convertible Stemmed Shoulder received FDA 510(k) clearance on 2022-11-10, under 510(k) number K222317.

Who is the listed applicant for Catalyst EA Convertible Stemmed Shoulder?

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

What is the FDA product code for Catalyst EA Convertible Stemmed Shoulder?

The FDA product code for Catalyst EA Convertible Stemmed Shoulder is KWS.

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Otros registros que enlistan a Catalyst Orthoscience, Inc. como solicitante

K252418Catalyst F1x Shoulder System K234105Catalyst F1x Shoulder System K232583Catalyst R1 Reverse Shoulder System K223655Catalyst R1 Reverse Shoulder System K213349Catalyst R1 Reverse Shoulder System K211991Catalyst R1 Reverse Shoulder System

Ver todos los 12 dispositivos →

Dispositivos relacionados (Código: KWS)

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084Sistema de Hombro AETOS - CONCELOC GlenoidsSmith & Nephew, Inc.K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K252416Prótesis Humeral Meta AETOS Shoulder System Size 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, Inc.)

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.