FDA 510(k)

インテグラ®キャプチャ™スクリューシステムおよびインテグラ®ティ6®内部固定システム

K番号: K162153 · 2017-07-14

決定日2017-07-14

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

Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Ascension Orthopedics. It received FDA 510(k) clearance on 2017-07-14 under 510(k) number K162153. 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 Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System?

Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System is a medical device that received FDA 510(k) clearance on 2017-07-14. The listed applicant is Ascension Orthopedics. The 510(k) number is K162153.

When did Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System receive FDA 510(k) clearance?

Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System received FDA 510(k) clearance on 2017-07-14, under 510(k) number K162153.

Who is the listed applicant for Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System?

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

What is the FDA product code for Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System?

The FDA product code for Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System is HWC. This falls under the Cardiovascular category.

申請者としてAscension Orthopedicsを記載するその他の記録

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