FDA 510(k)

Wagner SL修復支桿側邊，Wagner椎頂假體®系統

K 號：K161192 · 2016-07-08

決定日期2016-07-08

產品代碼LZO

諮詢委員會或

決定相當於

器材摘要

Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2016-07-08 under 510(k) number K161192. 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 Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System?

Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System is a medical device that received FDA 510(k) clearance on 2016-07-08. The listed applicant is Zimmer GmbH. The 510(k) number is K161192.

When did Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System receive FDA 510(k) clearance?

Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System received FDA 510(k) clearance on 2016-07-08, under 510(k) number K161192.

Who is the listed applicant for Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System?

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

What is the FDA product code for Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System?

The FDA product code for Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System is LZO.

其他以 Zimmer GmbH 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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