FDA 510(k)

Renovis A200 PS Knee System as part of the Renovis A200 Knee System

N.º K: K190122 · 2019-06-20

SolicitanteRenovis Surgical Technologies

Fecha de decisión2019-06-20

Código de productoJWH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Renovis A200 PS Knee System as part of the Renovis A200 Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Renovis Surgical Technologies. It received FDA 510(k) clearance on 2019-06-20 under 510(k) number K190122. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Renovis A200 PS Knee System as part of the Renovis A200 Knee System?

Renovis A200 PS Knee System as part of the Renovis A200 Knee System is a medical device that received FDA 510(k) clearance on 2019-06-20. The listed applicant is Renovis Surgical Technologies. The 510(k) number is K190122.

When did Renovis A200 PS Knee System as part of the Renovis A200 Knee System receive FDA 510(k) clearance?

Renovis A200 PS Knee System as part of the Renovis A200 Knee System received FDA 510(k) clearance on 2019-06-20, under 510(k) number K190122.

Who is the listed applicant for Renovis A200 PS Knee System as part of the Renovis A200 Knee System?

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

What is the FDA product code for Renovis A200 PS Knee System as part of the Renovis A200 Knee System?

The FDA product code for Renovis A200 PS Knee System as part of the Renovis A200 Knee System is JWH.

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Otros registros que enlistan a Renovis Surgical Technologies como solicitante

K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System K181655Renovis S180 Lateral Lumbar Interbody Fusion System K171543Renovis Surgical Hip Replacement System K170888Renovis S141 Lumbar Interbody Fusion System K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System

Dispositivos relacionados (Código: JWH)

K262057GMK ExtensionMedacta International SA K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130Sistema de Rodilla Revision ATTUNEDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

Fuente oficial

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