FDA 510(k)

Catalyst OrthoScience CSR Shoulder System

N.º K: K191811 · 2019-09-11

Fecha de decisión2019-09-11

Código de productoKWT

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Catalyst OrthoScience CSR 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 2019-09-11 under 510(k) number K191811. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Catalyst OrthoScience CSR Shoulder System?

Catalyst OrthoScience CSR Shoulder System is a medical device that received FDA 510(k) clearance on 2019-09-11. The listed applicant is Catalyst Orthoscience, Inc.. The 510(k) number is K191811.

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

Catalyst OrthoScience CSR Shoulder System received FDA 510(k) clearance on 2019-09-11, under 510(k) number K191811.

Who is the listed applicant for Catalyst OrthoScience CSR 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 OrthoScience CSR Shoulder System?

The FDA product code for Catalyst OrthoScience CSR Shoulder System is KWT.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 K222317Catalyst EA Convertible Stemmed Shoulder K213349Catalyst R1 Reverse Shoulder System

Ver todos los 12 dispositivos →

Dispositivos relacionados (Código: KWT)

K262173N22 Offset Humeral HeadShoulder Innovations, Inc.K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.K241944Sistema de Reemplazo de Hombro AGILON® XOImplantcast GmbH K241817InSet Total Shoulder SystemShoulder Innovations, Inc.K231657Sistema de Reemplazo de Hombro AGILON® XOImplantcast GmbH

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.