FDA 510(k)

ARIX 穿刺針システム

K番号: K192417 · 2019-11-26

決定日2019-11-26

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

ARIX Cannulated Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Jeil Medical Corporation. It received FDA 510(k) clearance on 2019-11-26 under 510(k) number K192417. 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 ARIX Cannulated Screw System?

ARIX Cannulated Screw System is a medical device that received FDA 510(k) clearance on 2019-11-26. The listed applicant is Jeil Medical Corporation. The 510(k) number is K192417.

When did ARIX Cannulated Screw System receive FDA 510(k) clearance?

ARIX Cannulated Screw System received FDA 510(k) clearance on 2019-11-26, under 510(k) number K192417.

Who is the listed applicant for ARIX Cannulated Screw System?

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

What is the FDA product code for ARIX Cannulated Screw System?

The FDA product code for ARIX Cannulated Screw System is HWC. This falls under the Cardiovascular category.

申請者としてJeil Medical Corporationを記載するその他の記録

K252246レフォートMMFシステム K252826ARIX 大腿骨ナイルシステム K251431FIX-C PEEK ACIF SA システム K243973FIX-L PEEK PLIFおよびT-PLIF システム K242751ARIX 胸骨バーシステム K242247ARIX 大腿骨ナイルシステム

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