FDA 510(k)

固定螺釘系統

K 號：K151701 · 2016-01-26

決定日期2016-01-26

產品代碼HWC

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器材摘要

Tenodesis screw system is the device name listed in this FDA 510(k) record. The listed applicant is Normed Medizin-Technik GmbH. It received FDA 510(k) clearance on 2016-01-26 under 510(k) number K151701. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the Tenodesis screw system?

Tenodesis screw system is a medical device that received FDA 510(k) clearance on 2016-01-26. The listed applicant is Normed Medizin-Technik GmbH. The 510(k) number is K151701.

When did Tenodesis screw system receive FDA 510(k) clearance?

Tenodesis screw system received FDA 510(k) clearance on 2016-01-26, under 510(k) number K151701.

Who is the listed applicant for Tenodesis screw system?

The FDA 510(k) record lists Normed Medizin-Technik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tenodesis screw system?

The FDA product code for Tenodesis screw system is HWC. This falls under the Cardiovascular category.

其他以 Normed Medizin-Technik GmbH 為申請人之記錄

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K151708RECON系統 - 压縮螺釘

相關器械（代碼：HWC）

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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