FDA 510(k)

Reliance Cervical IBF System

K番号: K172489 · 2017-09-07

決定日2017-09-07

製品コードODP

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

Reliance Cervical IBF System is the device name listed in this FDA 510(k) record. The listed applicant is Reliance Medical Systems, LLC. It received FDA 510(k) clearance on 2017-09-07 under 510(k) number K172489. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Reliance Cervical IBF System?

Reliance Cervical IBF System is a medical device that received FDA 510(k) clearance on 2017-09-07. The listed applicant is Reliance Medical Systems, LLC. The 510(k) number is K172489.

When did Reliance Cervical IBF System receive FDA 510(k) clearance?

Reliance Cervical IBF System received FDA 510(k) clearance on 2017-09-07, under 510(k) number K172489.

Who is the listed applicant for Reliance Cervical IBF System?

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

What is the FDA product code for Reliance Cervical IBF System?

The FDA product code for Reliance Cervical IBF System is ODP.

申請者としてReliance Medical Systems, LLCを記載するその他の記録

K202266Reliance Cervical IBF System K210874Reliance Spinal Screw System K183049Reliance Lumbar IBF System K173283Reliance Lumbar IBF System K173102Reliance Cervical IBF System K162066Reliance Spinal Screw System

すべての8件のデバイスを表示 →

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。