FDA 510(k)

Persona個人化膝關節系統（Persona OsseoTi 3-Peg 髖骨）

K 號：K240299 · 2024-04-26

決定日期2024-04-26

產品代碼MBH

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器材摘要

Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2024-04-26 under 510(k) number K240299. 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 Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)?

Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) is a medical device that received FDA 510(k) clearance on 2024-04-26. The listed applicant is Zimmer, Inc.. The 510(k) number is K240299.

When did Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) receive FDA 510(k) clearance?

Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) received FDA 510(k) clearance on 2024-04-26, under 510(k) number K240299.

Who is the listed applicant for Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)?

FDA 510(k) 記錄將 Zimmer, 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 Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)?

The FDA product code for Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) is MBH.

其他以 Zimmer, 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。

K262955OsseoFit無柄肩部系統 K260831Z1 髋關節系統 K261683Augment 偏心儀器系統 K251840齊默® 佩森娜® 適合個人化膝關節系統 K260182Avenir® Müller 植入物；Avenir Complete™ 髋關節系統 K253592Zimmer Biomet 反向肩蓋假體（Alliance 肱骨承重環，Identity 肱骨托盤，全面性反向肱骨托盤，全面性反向 32mm 髋球和適配器）

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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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