FDA 510(k)

デュプシンシストライアムラスクリュー

K番号: K192745 · 2019-11-26

申請者Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.

決定日2019-11-26

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

DePuy Synthes Trauma Screws is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2019-11-26 under 510(k) number K192745. 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 DePuy Synthes Trauma Screws?

DePuy Synthes Trauma Screws is a medical device that received FDA 510(k) clearance on 2019-11-26. The listed applicant is Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.. The 510(k) number is K192745.

When did DePuy Synthes Trauma Screws receive FDA 510(k) clearance?

DePuy Synthes Trauma Screws received FDA 510(k) clearance on 2019-11-26, under 510(k) number K192745.

Who is the listed applicant for DePuy Synthes Trauma Screws?

The FDA 510(k) record lists Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DePuy Synthes Trauma Screws?

The FDA product code for DePuy Synthes Trauma Screws is HWC. This falls under the Cardiovascular category.

申請者としてSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.を記載するその他の記録

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