FDA 510(k)

S4 スクリューシステム

K番号: K191995 · 2020-04-18

決定日2020-04-18

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

S4 Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Subchondral Solutions, Inc.. It received FDA 510(k) clearance on 2020-04-18 under 510(k) number K191995. 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 S4 Screw System?

S4 Screw System is a medical device that received FDA 510(k) clearance on 2020-04-18. The listed applicant is Subchondral Solutions, Inc.. The 510(k) number is K191995.

When did S4 Screw System receive FDA 510(k) clearance?

S4 Screw System received FDA 510(k) clearance on 2020-04-18, under 510(k) number K191995.

Who is the listed applicant for S4 Screw System?

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

What is the FDA product code for S4 Screw System?

The FDA product code for S4 Screw System is HWC. This falls under the Cardiovascular category.

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

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