FDA 510(k)

ActivOrtho Continuous Compression Screw System

K番号: K191817 · 2019-07-26

決定日2019-07-26

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

ActivOrtho Continuous Compression Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Activortho, Inc.. It received FDA 510(k) clearance on 2019-07-26 under 510(k) number K191817. 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 ActivOrtho Continuous Compression Screw System?

ActivOrtho Continuous Compression Screw System is a medical device that received FDA 510(k) clearance on 2019-07-26. The listed applicant is Activortho, Inc.. The 510(k) number is K191817.

When did ActivOrtho Continuous Compression Screw System receive FDA 510(k) clearance?

ActivOrtho Continuous Compression Screw System received FDA 510(k) clearance on 2019-07-26, under 510(k) number K191817.

Who is the listed applicant for ActivOrtho Continuous Compression Screw System?

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

What is the FDA product code for ActivOrtho Continuous Compression Screw System?

The FDA product code for ActivOrtho Continuous Compression Screw System is HWC. This falls under the Cardiovascular category.

申請者としてActivortho, Inc.を記載するその他の記録

K181610ActivOrtho Nitinol Compression Screw System

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。