FDA 510(k)

タイタスチタン頸椎装置 by サギコ

K番号: K221138 · 2023-08-04

決定日2023-08-04

製品コードOVE

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

Titus Titanium Cervical by SAGICO is the device name listed in this FDA 510(k) record. The listed applicant is Sagico VA USA, LLC. It received FDA 510(k) clearance on 2023-08-04 under 510(k) number K221138. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Titus Titanium Cervical by SAGICO?

Titus Titanium Cervical by SAGICO is a medical device that received FDA 510(k) clearance on 2023-08-04. The listed applicant is Sagico VA USA, LLC. The 510(k) number is K221138.

When did Titus Titanium Cervical by SAGICO receive FDA 510(k) clearance?

Titus Titanium Cervical by SAGICO received FDA 510(k) clearance on 2023-08-04, under 510(k) number K221138.

Who is the listed applicant for Titus Titanium Cervical by SAGICO?

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

What is the FDA product code for Titus Titanium Cervical by SAGICO?

The FDA product code for Titus Titanium Cervical by SAGICO is OVE.

申請者としてSagico VA USA, LLCを記載するその他の記録

K232561リプリー脊椎スクリューシステム by サギコ K223143SAGICO脊椎システム

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。