FDA 510(k)

齊默® 佩森娜® 適合個人化膝關節系統

K 號：K243293 · 2024-12-20

決定日期2024-12-20

產品代碼MBH

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器材摘要

Zimmer® Persona® Personalized Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Biomet. It received FDA 510(k) clearance on 2024-12-20 under 510(k) number K243293. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Zimmer® Persona® Personalized Knee System?

Zimmer® Persona® Personalized Knee System is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Zimmer Biomet. The 510(k) number is K243293.

When did Zimmer® Persona® Personalized Knee System receive FDA 510(k) clearance?

Zimmer® Persona® Personalized Knee System received FDA 510(k) clearance on 2024-12-20, under 510(k) number K243293.

Who is the listed applicant for Zimmer® Persona® Personalized Knee System?

FDA 510(k) 記錄將 Zimmer Biomet 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Zimmer® Persona® Personalized Knee System?

The FDA product code for Zimmer® Persona® Personalized Knee System is MBH.

其他以 Zimmer Biomet 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。

K261453G7® 髋臼系統 K251834人體部分膝蓋 K243571trabecular金屬骨盆修復系統，骨盆內襯及限制性內襯 K251620A.L.P.S. 近端肱骨板系統 K250834齊默比奧美陶瓷頭 (直徑 22.2mm)

相關器械（代碼：MBH）

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。

K261275Unity全膝系統，Unity膝水泥無縫股骨Corin, Ltd.K261462LANDMARK 全膝系統Smith & Nephew, Inc.K253728EVOLUTION® AM BIOFOAM® 道骨系統Microport Orthopedics, Inc.K251840齊默® 佩森娜® 適合個人化膝關節系統Zimmer, Inc.K253189Persona 個人化膝關節系統（Persona 多孔等离子喷涂 PPS 髋骨）Zimmer, Inc.K253328GMK 3D金屬胫骨托延伸器Medacta International S.A.

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。