FDA 510(k)

齊默® 佩森娜® 適合個人化膝關節系統

K 號：K251840 · 2026-05-28

決定日期2026-05-28

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, Inc.. It received FDA 510(k) clearance on 2026-05-28 under 510(k) number K251840. 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 2026-05-28. The listed applicant is Zimmer, Inc.. The 510(k) number is K251840.

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

Zimmer® Persona® Personalized Knee System received FDA 510(k) clearance on 2026-05-28, under 510(k) number K251840.

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

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 Zimmer® Persona® Personalized Knee System?

The FDA product code for Zimmer® Persona® Personalized Knee System 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 K261683Augment 偏心儀器系統 K260831Z1 髋關節系統 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）K253566Affixus 逆向股骨釘系統

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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.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.K253637Triathlon® 全膝系統 - Triathlon® X3® 中間穩定胫骨承插件Howmedica Osteonics Corp., Dba Stryker Orthopaedics

官方來源

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