FDA 510(k)

全腕關節置換系統 (TWA)

K 號：K243381 · 2024-11-01

決定日期2024-11-01

產品代碼JWJ

諮詢委員會或

決定相當於

器材摘要

Total Wrist Arthroplasty System (TWA) is the device name listed in this FDA 510(k) record. The listed applicant is Skeletal Dynamics, Inc.. It received FDA 510(k) clearance on 2024-11-01 under 510(k) number K243381. The device is classified under product code JWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Total Wrist Arthroplasty System (TWA)?

Total Wrist Arthroplasty System (TWA) is a medical device that received FDA 510(k) clearance on 2024-11-01. The listed applicant is Skeletal Dynamics, Inc.. The 510(k) number is K243381.

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

Total Wrist Arthroplasty System (TWA) received FDA 510(k) clearance on 2024-11-01, under 510(k) number K243381.

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

FDA 510(k) 記錄將 Skeletal Dynamics, Inc. 列為申請人。這並不單獨確立設備製造商。

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

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

其他以 Skeletal Dynamics, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：JWJ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K233574全腕關節置換系統 (TWA)Skeletal Dynamics K233674自由手腕關節成形系統Ascension Orthopedics, Inc.K200718Arthrosurface WristMotion 總腕關節置换系統Arthrosurface, Inc.K191525KinematX 全腕關節置換系統Extremity Medical, LLC

官方來源

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