FDA 510(k)

エピック・エクストリミティ・カニュレートド・スクリュー・システム

K番号: K153333 · 2016-01-19

決定日2016-01-19

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

Epic Extremity Cannulated Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Epic Extremity, LLC. It received FDA 510(k) clearance on 2016-01-19 under 510(k) number K153333. 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 Epic Extremity Cannulated Screw System?

Epic Extremity Cannulated Screw System is a medical device that received FDA 510(k) clearance on 2016-01-19. The listed applicant is Epic Extremity, LLC. The 510(k) number is K153333.

When did Epic Extremity Cannulated Screw System receive FDA 510(k) clearance?

Epic Extremity Cannulated Screw System received FDA 510(k) clearance on 2016-01-19, under 510(k) number K153333.

Who is the listed applicant for Epic Extremity Cannulated Screw System?

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

What is the FDA product code for Epic Extremity Cannulated Screw System?

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

申請者としてEpic Extremity, LLCを記載するその他の記録

K182991EPIC末梢融合プレートシステム K172441EPIC末梢骨折プレートシステム K163038EPIC末梢スナップオフボルト K153340エピック・エクストリミティ・プレート・システム

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。