FDA 510(k)

Total Wrist Arthroplasty System (TWA)

Номер K: K233574 · 2024-07-03

Дата решения2024-07-03

Код продуктаJWJ

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

Total Wrist Arthroplasty System (TWA) is the device name listed in this FDA 510(k) record. The listed applicant is Skeletal Dynamics. It received FDA 510(k) clearance on 2024-07-03 under 510(k) number K233574. The device is classified under product code JWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Total Wrist Arthroplasty System (TWA)?

Total Wrist Arthroplasty System (TWA) is a medical device that received FDA 510(k) clearance on 2024-07-03. The listed applicant is Skeletal Dynamics. The 510(k) number is K233574.

When did Total Wrist Arthroplasty System (TWA) receive FDA 510(k) clearance?

Total Wrist Arthroplasty System (TWA) received FDA 510(k) clearance on 2024-07-03, under 510(k) number K233574.

Who is the listed applicant for Total Wrist Arthroplasty System (TWA)?

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

What is the FDA product code for Total Wrist Arthroplasty System (TWA)?

The FDA product code for Total Wrist Arthroplasty System (TWA) is JWJ.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: JWJ)

K243381Total Wrist Arthroplasty System (TWA)Skeletal Dynamics, Inc.K233674Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc.K200718Arthrosurface система полного протезирования запястья WristMotionArthrosurface, Inc.K191525KinematX Total Wrist Arthroplasty SystemExtremity Medical, LLC

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