FDA 510(k)

COPAL膝模

K 號：K222570 · 2023-02-04

決定日期2023-02-04

產品代碼JWH

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決定相當於

器材摘要

COPAL knee moulds is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Medical GmbH. It received FDA 510(k) clearance on 2023-02-04 under 510(k) number K222570. 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 COPAL knee moulds?

COPAL knee moulds is a medical device that received FDA 510(k) clearance on 2023-02-04. The listed applicant is Heraeus Medical GmbH. The 510(k) number is K222570.

When did COPAL knee moulds receive FDA 510(k) clearance?

COPAL knee moulds received FDA 510(k) clearance on 2023-02-04, under 510(k) number K222570.

Who is the listed applicant for COPAL knee moulds?

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

What is the FDA product code for COPAL knee moulds?

The FDA product code for COPAL knee moulds is JWH.

其他以 Heraeus Medical GmbH 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。

K241674OSTEOPAL® V K234028COPAL®交換G股間隔器；COPAL®G+V K220492COPAL交換G 髋間隔離器 K213812PAHALOS MV pro K210607PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro K202475PALACOS R、PALACOS R pro、PALACOS R+G、PALACOS R+G pro、PALACOS MV+G

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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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