FDA 510(k)

バイオコア9 肩関節表面再構成システム

K番号: K193122 · 2020-05-15

決定日2020-05-15

製品コードHSD

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

Biocore9 Humeral Resurfacing System is the device name listed in this FDA 510(k) record. The listed applicant is Biocore9, LLC. It received FDA 510(k) clearance on 2020-05-15 under 510(k) number K193122. The device is classified under product code HSD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Biocore9 Humeral Resurfacing System?

Biocore9 Humeral Resurfacing System is a medical device that received FDA 510(k) clearance on 2020-05-15. The listed applicant is Biocore9, LLC. The 510(k) number is K193122.

When did Biocore9 Humeral Resurfacing System receive FDA 510(k) clearance?

Biocore9 Humeral Resurfacing System received FDA 510(k) clearance on 2020-05-15, under 510(k) number K193122.

Who is the listed applicant for Biocore9 Humeral Resurfacing System?

The FDA 510(k) record lists Biocore9, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biocore9 Humeral Resurfacing System?

The FDA product code for Biocore9 Humeral Resurfacing System is HSD.

申請者としてBiocore9, LLCを記載するその他の記録

K212761バイオコア9 骨盂杯システム K201219バイオコア9大腿骨頭表面再構成部品

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。