FDA 510(k)

ExsoMed INnate Nano™ ラグスクリューシステム

K番号: K220892 · 2022-04-27

決定日2022-04-27

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

ExsoMed INnate NanoTM Lag Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Exsomed Corp.. It received FDA 510(k) clearance on 2022-04-27 under 510(k) number K220892. 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 ExsoMed INnate NanoTM Lag Screw System?

ExsoMed INnate NanoTM Lag Screw System is a medical device that received FDA 510(k) clearance on 2022-04-27. The listed applicant is Exsomed Corp.. The 510(k) number is K220892.

When did ExsoMed INnate NanoTM Lag Screw System receive FDA 510(k) clearance?

ExsoMed INnate NanoTM Lag Screw System received FDA 510(k) clearance on 2022-04-27, under 510(k) number K220892.

Who is the listed applicant for ExsoMed INnate NanoTM Lag Screw System?

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

What is the FDA product code for ExsoMed INnate NanoTM Lag Screw System?

The FDA product code for ExsoMed INnate NanoTM Lag Screw System is HWC. This falls under the Cardiovascular category.

申請者としてExsomed Corp.を記載するその他の記録

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