FDA 510(k)

OS2(R)-VP 適應性釘針

K 號：K153770 · 2016-03-21

決定日期2016-03-21

產品代碼JDR

諮詢委員會或

決定相當於

器材摘要

OS2(R)-VP Varisation Staple is the device name listed in this FDA 510(k) record. The listed applicant is In2bones Sas. It received FDA 510(k) clearance on 2016-03-21 under 510(k) number K153770. 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 OS2(R)-VP Varisation Staple?

OS2(R)-VP Varisation Staple is a medical device that received FDA 510(k) clearance on 2016-03-21. The listed applicant is In2bones Sas. The 510(k) number is K153770.

When did OS2(R)-VP Varisation Staple receive FDA 510(k) clearance?

OS2(R)-VP Varisation Staple received FDA 510(k) clearance on 2016-03-21, under 510(k) number K153770.

Who is the listed applicant for OS2(R)-VP Varisation Staple?

The FDA 510(k) record lists In2bones Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OS2(R)-VP Varisation Staple?

The FDA product code for OS2(R)-VP Varisation Staple is JDR.

其他以 In2bones Sas 為申請人之記錄

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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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