FDA 510(k)

Z1 髋關節系統

K 號：K260831 · 2026-06-16

決定日期2026-06-16

產品代碼LZO

諮詢委員會或

決定相當於

器材摘要

Z1 Hip 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 2026-06-16 under 510(k) number K260831. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Z1 Hip System?

Z1 Hip System is a medical device that received FDA 510(k) clearance on 2026-06-16. The listed applicant is Zimmer, Inc.. The 510(k) number is K260831.

When did Z1 Hip System receive FDA 510(k) clearance?

Z1 Hip System received FDA 510(k) clearance on 2026-06-16, under 510(k) number K260831.

Who is the listed applicant for Z1 Hip 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 Z1 Hip System?

The FDA product code for Z1 Hip System is LZO.

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。

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相關器械（代碼：LZO）

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。

K260173M-Vizion 髋關節更換系統擴充版Medacta International S.A.K253948動力骨盂杯系統United Orthopedic Corporation K261009MobileLink 骨盆杯系統 – 40mm ID 插片（各種）Waldemar Link GmbH & Co. KG K260182Avenir® Müller 植入物；Avenir Complete™ 髋關節系統Zimmer, Inc.K260037植入式醫療設備包裝系統更新Implantcast GmbH K252401implaFit®短柄Implantcast GmbH

官方來源

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