FDA 510(k)

デュプイ・シンセストラウマ整形板およびボルト

K番号: K180310 · 2018-11-01

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

決定日2018-11-01

製品コードHRS

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 Orthopedic Plates and 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 2018-11-01 under 510(k) number K180310. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the DePuy Synthes Trauma Orthopedic Plates and Screws?

DePuy Synthes Trauma Orthopedic Plates and Screws is a medical device that received FDA 510(k) clearance on 2018-11-01. The listed applicant is Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.. The 510(k) number is K180310.

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

DePuy Synthes Trauma Orthopedic Plates and Screws received FDA 510(k) clearance on 2018-11-01, under 510(k) number K180310.

Who is the listed applicant for DePuy Synthes Trauma Orthopedic Plates and 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 Orthopedic Plates and Screws?

The FDA product code for DePuy Synthes Trauma Orthopedic Plates and Screws is HRS.

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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