FDA 510(k)

再處理史賓格外固定設備

K 號：K153415 · 2016-01-13

決定日期2016-01-13

產品代碼KTT

諮詢委員會或

決定相當於

器材摘要

Reprocessed Stryker External Fixation Devices is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Sustainability Solutions. It received FDA 510(k) clearance on 2016-01-13 under 510(k) number K153415. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Reprocessed Stryker External Fixation Devices?

Reprocessed Stryker External Fixation Devices is a medical device that received FDA 510(k) clearance on 2016-01-13. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K153415.

When did Reprocessed Stryker External Fixation Devices receive FDA 510(k) clearance?

Reprocessed Stryker External Fixation Devices received FDA 510(k) clearance on 2016-01-13, under 510(k) number K153415.

Who is the listed applicant for Reprocessed Stryker External Fixation Devices?

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

What is the FDA product code for Reprocessed Stryker External Fixation Devices?

The FDA product code for Reprocessed Stryker External Fixation Devices is KTT.

其他以 Stryker Sustainability Solutions 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。

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相關器械（代碼：KTT）

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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