FDA 510(k)

テノデーシスボルトシステム

K番号: K151701 · 2016-01-26

決定日2016-01-26

製品コードHWC

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてNormed Medizin-Technik GmbHを記載するその他の記録

K151708RECONシステム - コンプレッションボルト

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