FDA 510(k)

SECUREボルト

K番号: K191771 · 2019-10-16

決定日2019-10-16

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

SECURE Screw is the device name listed in this FDA 510(k) record. The listed applicant is A.M. Surgical, Inc.. It received FDA 510(k) clearance on 2019-10-16 under 510(k) number K191771. 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 SECURE Screw?

SECURE Screw is a medical device that received FDA 510(k) clearance on 2019-10-16. The listed applicant is A.M. Surgical, Inc.. The 510(k) number is K191771.

When did SECURE Screw receive FDA 510(k) clearance?

SECURE Screw received FDA 510(k) clearance on 2019-10-16, under 510(k) number K191771.

Who is the listed applicant for SECURE Screw?

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

What is the FDA product code for SECURE Screw?

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

申請者としてA.M. Surgical, Inc.を記載するその他の記録

K191345ペガスス・システム K180087A.M. 手術内骨髄固定装置

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