FDA 510(k)

HBS2 ヘッドレスボーンスクリュー

K番号: K171628 · 2018-01-12

決定日2018-01-12

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

HBS2 Headless Bone Screw is the device name listed in this FDA 510(k) record. The listed applicant is Stuckenbrock Medizintechnik GmbH. It received FDA 510(k) clearance on 2018-01-12 under 510(k) number K171628. 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 HBS2 Headless Bone Screw?

HBS2 Headless Bone Screw is a medical device that received FDA 510(k) clearance on 2018-01-12. The listed applicant is Stuckenbrock Medizintechnik GmbH. The 510(k) number is K171628.

When did HBS2 Headless Bone Screw receive FDA 510(k) clearance?

HBS2 Headless Bone Screw received FDA 510(k) clearance on 2018-01-12, under 510(k) number K171628.

Who is the listed applicant for HBS2 Headless Bone Screw?

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

What is the FDA product code for HBS2 Headless Bone Screw?

The FDA product code for HBS2 Headless Bone Screw is HWC. This falls under the Cardiovascular category.

申請者としてStuckenbrock Medizintechnik GmbHを記載するその他の記録

K171624IXOS レジデンスプレートシステム

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