FDA 510(k)

斯崔克聲波釘系統

K 號：K170418 · 2017-06-20

決定日期2017-06-20

產品代碼HTY

諮詢委員會或

決定相當於

器材摘要

Stryker SonicPin System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Trauma GmbH. It received FDA 510(k) clearance on 2017-06-20 under 510(k) number K170418. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Stryker SonicPin System?

Stryker SonicPin System is a medical device that received FDA 510(k) clearance on 2017-06-20. The listed applicant is Stryker Trauma GmbH. The 510(k) number is K170418.

When did Stryker SonicPin System receive FDA 510(k) clearance?

Stryker SonicPin System received FDA 510(k) clearance on 2017-06-20, under 510(k) number K170418.

Who is the listed applicant for Stryker SonicPin System?

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

What is the FDA product code for Stryker SonicPin System?

The FDA product code for Stryker SonicPin System is HTY.

其他以 Stryker Trauma GmbH 為申請人之記錄

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相關器械（代碼：HTY）

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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