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FDA 510(k)

Tritanium® PL Cage

K 號:K160955 · 2016-07-21

申請人Stryker
決定日期2016-07-21
產品代碼MAX
諮詢委員會OR
決定Substantially Equivalent

器材摘要

Tritanium® PL Cage is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2016-07-21 under 510(k) number K160955. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tritanium® PL Cage?

Tritanium® PL Cage is a medical device that received FDA 510(k) clearance on 2016-07-21. The listed applicant is Stryker. The 510(k) number is K160955.

When did Tritanium® PL Cage receive FDA 510(k) clearance?

Tritanium® PL Cage received FDA 510(k) clearance on 2016-07-21, under 510(k) number K160955.

Who is the listed applicant for Tritanium® PL Cage?

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

What is the FDA product code for Tritanium® PL Cage?

The FDA product code for Tritanium® PL Cage is MAX.

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其他以 Stryker 為申請人之記錄

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相關器械(代碼:MAX)

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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