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FDA 510(k)

Z1 髋關節系統

K 號:K233476 · 2024-02-08

決定日期2024-02-08
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 Orchard Medical Development. It received FDA 510(k) clearance on 2024-02-08 under 510(k) number K233476. 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 2024-02-08. The listed applicant is Orchard Medical Development. The 510(k) number is K233476.

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

Z1 Hip System received FDA 510(k) clearance on 2024-02-08, under 510(k) number K233476.

Who is the listed applicant for Z1 Hip System?

The FDA 510(k) record lists Orchard Medical Development as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Z1 Hip System?

The FDA product code for Z1 Hip System is LZO.

相關臨床試驗

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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。

官方來源

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