FDA 510(k)

Catalyst F1x Shoulder System

Número K: K252418 · 2025-11-06

Data da decisão2025-11-06

Código do produtoKWS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Catalyst F1x Shoulder System 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 2025-11-06 under 510(k) number K252418. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Catalyst F1x Shoulder System?

Catalyst F1x Shoulder System is a medical device that received FDA 510(k) clearance on 2025-11-06. The listed applicant is Catalyst Orthoscience, Inc.. The 510(k) number is K252418.

When did Catalyst F1x Shoulder System receive FDA 510(k) clearance?

Catalyst F1x Shoulder System received FDA 510(k) clearance on 2025-11-06, under 510(k) number K252418.

Who is the listed applicant for Catalyst F1x Shoulder System?

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 F1x Shoulder System?

The FDA product code for Catalyst F1x Shoulder System is KWS.

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Outros registros que listam Catalyst Orthoscience, Inc. como candidato(a)

K234105Catalyst F1x Shoulder System K232583Catalyst R1 Reverse Shoulder System K223655Catalyst R1 Reverse Shoulder System K222317Catalyst EA Convertible Stemmed Shoulder K213349Catalyst R1 Reverse Shoulder System K211991Catalyst R1 Reverse Shoulder System

Ver todos os 12 dispositivos →

Dispositivos Relacionados (Código: KWS)

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084Sistema de Ombro AETOS - CONCELOC GlenoidsSmith & Nephew, Inc.K252416Prótese Metacôndila 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.)K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)

Fonte oficial

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