FDA 510(k)

CREED™ 穿通ボルト

K番号: K200291 · 2020-12-16

決定日2020-12-16

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

CREED™ Cannulated Screws is the device name listed in this FDA 510(k) record. The listed applicant is Glw Medical, Inc.. It received FDA 510(k) clearance on 2020-12-16 under 510(k) number K200291. 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 CREED™ Cannulated Screws?

CREED™ Cannulated Screws is a medical device that received FDA 510(k) clearance on 2020-12-16. The listed applicant is Glw Medical, Inc.. The 510(k) number is K200291.

When did CREED™ Cannulated Screws receive FDA 510(k) clearance?

CREED™ Cannulated Screws received FDA 510(k) clearance on 2020-12-16, under 510(k) number K200291.

Who is the listed applicant for CREED™ Cannulated Screws?

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

What is the FDA product code for CREED™ Cannulated Screws?

The FDA product code for CREED™ Cannulated Screws is HWC. This falls under the Cardiovascular category.

申請者としてGlw Medical, Inc.を記載するその他の記録

K213005Apollo 足骨折プレートシステム

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。