FDA 510(k)

Stealth 隱形釘系統

K 號：K163440 · 2017-02-01

決定日期2017-02-01

產品代碼JDR

諮詢委員會或

決定相當於

器材摘要

Stealth Staple System is the device name listed in this FDA 510(k) record. The listed applicant is First Ray, LLC. It received FDA 510(k) clearance on 2017-02-01 under 510(k) number K163440. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Stealth Staple System?

Stealth Staple System is a medical device that received FDA 510(k) clearance on 2017-02-01. The listed applicant is First Ray, LLC. The 510(k) number is K163440.

When did Stealth Staple System receive FDA 510(k) clearance?

Stealth Staple System received FDA 510(k) clearance on 2017-02-01, under 510(k) number K163440.

Who is the listed applicant for Stealth Staple System?

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

What is the FDA product code for Stealth Staple System?

The FDA product code for Stealth Staple System is JDR.

其他以 First Ray, LLC 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：JDR）

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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