FDA 510(k)

骨髄ボール圧縮ボルト

K番号: K160304 · 2016-04-29

決定日2016-04-29

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

OsteoBullet Compression Screw is the device name listed in this FDA 510(k) record. The listed applicant is Phalanx Innovations. It received FDA 510(k) clearance on 2016-04-29 under 510(k) number K160304. 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 OsteoBullet Compression Screw?

OsteoBullet Compression Screw is a medical device that received FDA 510(k) clearance on 2016-04-29. The listed applicant is Phalanx Innovations. The 510(k) number is K160304.

When did OsteoBullet Compression Screw receive FDA 510(k) clearance?

OsteoBullet Compression Screw received FDA 510(k) clearance on 2016-04-29, under 510(k) number K160304.

Who is the listed applicant for OsteoBullet Compression Screw?

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

What is the FDA product code for OsteoBullet Compression Screw?

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

申請者としてPhalanx Innovationsを記載するその他の記録

K160194スターフューズ指間関節ピン

公式ソース

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