FDA 510(k)

CurvaFix 内腔骨棒システム

K番号: K180050 · 2019-03-01

決定日2019-03-01

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

CurvaFix Intramedullary Rodscrew System is the device name listed in this FDA 510(k) record. The listed applicant is Curvafix, Inc.. It received FDA 510(k) clearance on 2019-03-01 under 510(k) number K180050. 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 CurvaFix Intramedullary Rodscrew System?

CurvaFix Intramedullary Rodscrew System is a medical device that received FDA 510(k) clearance on 2019-03-01. The listed applicant is Curvafix, Inc.. The 510(k) number is K180050.

When did CurvaFix Intramedullary Rodscrew System receive FDA 510(k) clearance?

CurvaFix Intramedullary Rodscrew System received FDA 510(k) clearance on 2019-03-01, under 510(k) number K180050.

Who is the listed applicant for CurvaFix Intramedullary Rodscrew System?

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

What is the FDA product code for CurvaFix Intramedullary Rodscrew System?

The FDA product code for CurvaFix Intramedullary Rodscrew System is HWC. This falls under the Cardiovascular category.

申請者としてCurvafix, Inc.を記載するその他の記録

K252019CurvaFix ローポロフィールシステム K222505CurvaFix IM システム

公式ソース

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