FDA 510(k)

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K番号: K191289 · 2019-07-29

決定日2019-07-29

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

Bone Screw Line Addition is the device name listed in this FDA 510(k) record. The listed applicant is Vilex IN Tennessee, Inc.. It received FDA 510(k) clearance on 2019-07-29 under 510(k) number K191289. 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 Bone Screw Line Addition?

Bone Screw Line Addition is a medical device that received FDA 510(k) clearance on 2019-07-29. The listed applicant is Vilex IN Tennessee, Inc.. The 510(k) number is K191289.

When did Bone Screw Line Addition receive FDA 510(k) clearance?

Bone Screw Line Addition received FDA 510(k) clearance on 2019-07-29, under 510(k) number K191289.

Who is the listed applicant for Bone Screw Line Addition?

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

What is the FDA product code for Bone Screw Line Addition?

The FDA product code for Bone Screw Line Addition is HWC. This falls under the Cardiovascular category.

申請者としてVilex IN Tennessee, Inc.を記載するその他の記録

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