FDA 510(k)

Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post

N.º K: K232414 · 2023-09-08

Fecha de decisión2023-09-08

Código de productoJWH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post 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 2023-09-08 under 510(k) number K232414. 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® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post?

Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is Total Joint Othopedics, Inc.. The 510(k) number is K232414.

When did Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post receive FDA 510(k) clearance?

Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post received FDA 510(k) clearance on 2023-09-08, under 510(k) number K232414.

Who is the listed applicant for Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post?

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® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post?

The FDA product code for Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post is JWH.

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

K243991Klassic Knee System - Revision Tibial Baseplate K230537Klassic Knee Revision System K213580Manga Adaptadora para Cabeza Femoral BIOLOX® OPTION, +10.5mm longitud de cabeza K191399BIOLOX CONTOURA Ceramic Femoral Head K171962Klassic HD® Hip System K161073Klassic HD Hip System

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Dispositivos relacionados (Código: JWH)

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Fuente oficial

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