FDA 510(k)

ACS® LD FB 適合膝關節系統

K 號：K234044 · 2024-09-06

決定日期2024-09-06

產品代碼JWH

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決定相當於

器材摘要

ACS® LD FB Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Implantcast GmbH. It received FDA 510(k) clearance on 2024-09-06 under 510(k) number K234044. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ACS® LD FB Knee System?

ACS® LD FB Knee System is a medical device that received FDA 510(k) clearance on 2024-09-06. The listed applicant is Implantcast GmbH. The 510(k) number is K234044.

When did ACS® LD FB Knee System receive FDA 510(k) clearance?

ACS® LD FB Knee System received FDA 510(k) clearance on 2024-09-06, under 510(k) number K234044.

Who is the listed applicant for ACS® LD FB Knee System?

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

What is the FDA product code for ACS® LD FB Knee System?

The FDA product code for ACS® LD FB Knee System is JWH.

其他以 Implantcast GmbH 為申請人之記錄

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相關器械（代碼：JWH）

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。

K262057GMK 扩充設備Medacta International SA K260063GSPE 分隔器The General Hospital Corporation, d/b/a Massachusetts K262293EVOLUTION MPX™ 全膝系統Suzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ 全膝系統修復水泥固定胫骨增強器、樹枝擴展和壓入式樹枝擴展B-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK膝關節系統Just Medical Devices (Tianjin) Co., Ltd.

官方來源

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