FDA 510(k)

SP-CL 髋關節柄及 LCU 髋關節系統

K 號：K213770 · 2022-09-13

決定日期2022-09-13

產品代碼LZO

諮詢委員會或

決定相當於

器材摘要

SP-CL Hip Stem and LCU Hip System is the device name listed in this FDA 510(k) record. The listed applicant is Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2022-09-13 under 510(k) number K213770. 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 SP-CL Hip Stem and LCU Hip System?

SP-CL Hip Stem and LCU Hip System is a medical device that received FDA 510(k) clearance on 2022-09-13. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K213770.

When did SP-CL Hip Stem and LCU Hip System receive FDA 510(k) clearance?

SP-CL Hip Stem and LCU Hip System received FDA 510(k) clearance on 2022-09-13, under 510(k) number K213770.

Who is the listed applicant for SP-CL Hip Stem and LCU Hip System?

The FDA 510(k) record lists Waldemar Link GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SP-CL Hip Stem and LCU Hip System?

The FDA product code for SP-CL Hip Stem and LCU Hip System is LZO.

其他以 Waldemar Link GmbH & Co. KG 為申請人之記錄

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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。

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