FDA 510(k)

COPAL®交換G股間隔器；COPAL®G+V

K 號：K234028 · 2024-02-15

決定日期2024-02-15

產品代碼KWL

諮詢委員會或

決定相當於

器材摘要

COPAL® exchange G hip spacer; COPAL® G+V 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 2024-02-15 under 510(k) number K234028. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the COPAL® exchange G hip spacer; COPAL® G+V?

COPAL® exchange G hip spacer; COPAL® G+V is a medical device that received FDA 510(k) clearance on 2024-02-15. The listed applicant is Heraeus Medical GmbH. The 510(k) number is K234028.

When did COPAL® exchange G hip spacer; COPAL® G+V receive FDA 510(k) clearance?

COPAL® exchange G hip spacer; COPAL® G+V received FDA 510(k) clearance on 2024-02-15, under 510(k) number K234028.

Who is the listed applicant for COPAL® exchange G hip spacer; COPAL® G+V?

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® exchange G hip spacer; COPAL® G+V?

The FDA product code for COPAL® exchange G hip spacer; COPAL® G+V is KWL.

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 K222570COPAL膝模 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：KWL）

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。

K262290REMEDY POLY+PLUS 快速適合髋白杯Osteoremedies, LLC K260536Prostalac 髋關節系統，SmartSet V+G雙抗生素骨水泥Depuy Ireland UC K253675骨修療股骨間隙系統Osteoremedies, LLC K252326InterSpace GV 髋關節間隔器Tecres S.P.A.K242865Synicem 髋關節間隔器；Synicem 開節間隔器；Synicem 肩關節間隔器Biocomposites, Ltd.K222632UHR雙極植入體，Restoration GAP II 植入體Howmedica Osteonics Corp., Dba Stryker Orthopaedics

官方來源

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