FDA 510(k)

IFS固定装置システム

K番号: K152627 · 2016-01-13

決定日2016-01-13

製品コードHTY

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

IFS Fixation Scaffold System is the device name listed in this FDA 510(k) record. The listed applicant is Metric Medical Devices, Inc.. It received FDA 510(k) clearance on 2016-01-13 under 510(k) number K152627. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the IFS Fixation Scaffold System?

IFS Fixation Scaffold System is a medical device that received FDA 510(k) clearance on 2016-01-13. The listed applicant is Metric Medical Devices, Inc.. The 510(k) number is K152627.

When did IFS Fixation Scaffold System receive FDA 510(k) clearance?

IFS Fixation Scaffold System received FDA 510(k) clearance on 2016-01-13, under 510(k) number K152627.

Who is the listed applicant for IFS Fixation Scaffold System?

The FDA 510(k) record lists Metric Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IFS Fixation Scaffold System?

The FDA product code for IFS Fixation Scaffold System is HTY.

申請者としてMetric Medical Devices, Inc.を記載するその他の記録

K240049リンク（TM）外固定器

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。