FDA 510(k)

フォルマメディカルヘッドレスコンプレッションスクリュー

K番号: K230945 · 2023-07-18

決定日2023-07-18

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

Forma Medical Headless Compression Screw is the device name listed in this FDA 510(k) record. The listed applicant is Forma Medical, Inc.. It received FDA 510(k) clearance on 2023-07-18 under 510(k) number K230945. 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 Forma Medical Headless Compression Screw?

Forma Medical Headless Compression Screw is a medical device that received FDA 510(k) clearance on 2023-07-18. The listed applicant is Forma Medical, Inc.. The 510(k) number is K230945.

When did Forma Medical Headless Compression Screw receive FDA 510(k) clearance?

Forma Medical Headless Compression Screw received FDA 510(k) clearance on 2023-07-18, under 510(k) number K230945.

Who is the listed applicant for Forma Medical Headless Compression Screw?

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

What is the FDA product code for Forma Medical Headless Compression Screw?

The FDA product code for Forma Medical Headless Compression Screw is HWC. This falls under the Cardiovascular category.

申請者としてForma Medical, Inc.を記載するその他の記録

K234059フォルマ・メディカルオプティマルプレートイングシステム

公式ソース

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