FDA 510(k)

Klassic Knee Revision System

Número K: K230537 · 2023-05-19

Data da decisão2023-05-19

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Klassic Knee Revision System is the device name listed in this FDA 510(k) record. The listed applicant is Total Joint Othopedics, Inc.. It received FDA 510(k) clearance on 2023-05-19 under 510(k) number K230537. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Klassic Knee Revision System?

Klassic Knee Revision System is a medical device that received FDA 510(k) clearance on 2023-05-19. The listed applicant is Total Joint Othopedics, Inc.. The 510(k) number is K230537.

When did Klassic Knee Revision System receive FDA 510(k) clearance?

Klassic Knee Revision System received FDA 510(k) clearance on 2023-05-19, under 510(k) number K230537.

Who is the listed applicant for Klassic Knee Revision System?

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

What is the FDA product code for Klassic Knee Revision System?

The FDA product code for Klassic Knee Revision System is JWH.

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Outros registros que listam Total Joint Othopedics, Inc. como candidato(a)

K243991Klassic Knee System - Revision Tibial Baseplate K232414Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm comprimento da cabeça K191399BIOLOX CONTOURA Ceramic Femoral Head K171962Klassic HD® Hip System K161073Klassic HD Hip System

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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.K262130ATTUNE Sistema de Quadril de RevisãoDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

Fonte oficial

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