FDA 510(k)

バトン・ユニバーサル・スペーサー・システム

K番号: K160958 · 2016-09-08

決定日2016-09-08

製品コードPHM

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

Battalion Universal Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine. It received FDA 510(k) clearance on 2016-09-08 under 510(k) number K160958. The device is classified under product code PHM. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Battalion Universal Spacer System?

Battalion Universal Spacer System is a medical device that received FDA 510(k) clearance on 2016-09-08. The listed applicant is Alphatec Spine. The 510(k) number is K160958.

When did Battalion Universal Spacer System receive FDA 510(k) clearance?

Battalion Universal Spacer System received FDA 510(k) clearance on 2016-09-08, under 510(k) number K160958.

Who is the listed applicant for Battalion Universal Spacer System?

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

What is the FDA product code for Battalion Universal Spacer System?

The FDA product code for Battalion Universal Spacer System is PHM.

申請者としてAlphatec Spineを記載するその他の記録

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。