FDA 510(k)

MasterLoc 腳跟處理器

K 號：K160289 · 2016-05-20

決定日期2016-05-20

產品代碼LZO

諮詢委員會或

決定相當於

器材摘要

MasterLoc Stem is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International. It received FDA 510(k) clearance on 2016-05-20 under 510(k) number K160289. 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 MasterLoc Stem?

MasterLoc Stem is a medical device that received FDA 510(k) clearance on 2016-05-20. The listed applicant is Medacta International. The 510(k) number is K160289.

When did MasterLoc Stem receive FDA 510(k) clearance?

MasterLoc Stem received FDA 510(k) clearance on 2016-05-20, under 510(k) number K160289.

Who is the listed applicant for MasterLoc Stem?

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

What is the FDA product code for MasterLoc Stem?

The FDA product code for MasterLoc Stem is LZO.

其他以 Medacta International 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。

K160605MectaLIF 前置獨立支架 K153664M.U.S.T. 椎骨螺釘系統

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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