FDA 510(k)

シンプルフィックスヒップシステム

K番号: K230053 · 2023-04-19

決定日2023-04-19

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

SimpliFix Hip System is the device name listed in this FDA 510(k) record. The listed applicant is Stabiliz Orthopaedics, Inc.. It received FDA 510(k) clearance on 2023-04-19 under 510(k) number K230053. 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 SimpliFix Hip System?

SimpliFix Hip System is a medical device that received FDA 510(k) clearance on 2023-04-19. The listed applicant is Stabiliz Orthopaedics, Inc.. The 510(k) number is K230053.

When did SimpliFix Hip System receive FDA 510(k) clearance?

SimpliFix Hip System received FDA 510(k) clearance on 2023-04-19, under 510(k) number K230053.

Who is the listed applicant for SimpliFix Hip System?

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

What is the FDA product code for SimpliFix Hip System?

The FDA product code for SimpliFix Hip System is HWC. This falls under the Cardiovascular category.

申請者としてStabiliz Orthopaedics, Inc.を記載するその他の記録

K260112QuikFix 外固定器：膝関節パック

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