FDA 510(k)

Klassic Knee System Tibial Inserts, PS-Max

N.º K: K202740 · 2020-10-09

SolicitanteTotal Joint Orthopedics, Inc.

Fecha de decisión2020-10-09

Código de productoJWH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Klassic Knee System Tibial Inserts, PS-Max is the device name listed in this FDA 510(k) record. The listed applicant is Total Joint Orthopedics, Inc.. It received FDA 510(k) clearance on 2020-10-09 under 510(k) number K202740. 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 Klassic Knee System Tibial Inserts, PS-Max?

Klassic Knee System Tibial Inserts, PS-Max is a medical device that received FDA 510(k) clearance on 2020-10-09. The listed applicant is Total Joint Orthopedics, Inc.. The 510(k) number is K202740.

When did Klassic Knee System Tibial Inserts, PS-Max receive FDA 510(k) clearance?

Klassic Knee System Tibial Inserts, PS-Max received FDA 510(k) clearance on 2020-10-09, under 510(k) number K202740.

Who is the listed applicant for Klassic Knee System Tibial Inserts, PS-Max?

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

What is the FDA product code for Klassic Knee System Tibial Inserts, PS-Max?

The FDA product code for Klassic Knee System Tibial Inserts, PS-Max is JWH.

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Otros registros que enlistan a Total Joint Orthopedics, Inc. como solicitante

K261734Klassic Infection Spacer System K220483Platform® Acetabular System K211877Klassic Knee System K211602Klassic Knee System K183596Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly K190280Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly

Ver todos los 12 dispositivos →

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

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.