FDA 510(k)

関節融合装置範囲

K番号: K191424 · 2019-08-28

決定日2019-08-28

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Substantially Equivalent

医療機器の概要

Interphalangeal Joint Fusion Device Range is the device name listed in this FDA 510(k) record. The listed applicant is Neosteo. It received FDA 510(k) clearance on 2019-08-28 under 510(k) number K191424. 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 Interphalangeal Joint Fusion Device Range?

Interphalangeal Joint Fusion Device Range is a medical device that received FDA 510(k) clearance on 2019-08-28. The listed applicant is Neosteo. The 510(k) number is K191424.

When did Interphalangeal Joint Fusion Device Range receive FDA 510(k) clearance?

Interphalangeal Joint Fusion Device Range received FDA 510(k) clearance on 2019-08-28, under 510(k) number K191424.

Who is the listed applicant for Interphalangeal Joint Fusion Device Range?

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

What is the FDA product code for Interphalangeal Joint Fusion Device Range?

The FDA product code for Interphalangeal Joint Fusion Device Range is HWC. This falls under the Cardiovascular category.

申請者としてNeosteoを記載するその他の記録

K212545FlexitSystem膝関節切除システム K192447Superelastic Staple

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