FDA 510(k)

StageOne™ 選擇式髋關節水泥間隔模具

K 號：K222760 · 2022-12-28

決定日期2022-12-28

產品代碼MBB

諮詢委員會或

決定相當於

器材摘要

StageOne™ Select Hip Cement Spacer Molds is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2022-12-28 under 510(k) number K222760. The device is classified under product code MBB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the StageOne™ Select Hip Cement Spacer Molds?

StageOne™ Select Hip Cement Spacer Molds is a medical device that received FDA 510(k) clearance on 2022-12-28. The listed applicant is Biomet, Inc.. The 510(k) number is K222760.

When did StageOne™ Select Hip Cement Spacer Molds receive FDA 510(k) clearance?

StageOne™ Select Hip Cement Spacer Molds received FDA 510(k) clearance on 2022-12-28, under 510(k) number K222760.

Who is the listed applicant for StageOne™ Select Hip Cement Spacer Molds?

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

What is the FDA product code for StageOne™ Select Hip Cement Spacer Molds?

The FDA product code for StageOne™ Select Hip Cement Spacer Molds is MBB.

其他以 Biomet, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253434OSSTM 骨科救護系統 K251270Taperloc® 完整股骨柄 K241014比奧美特克irschner針（K針）K221968StageOne™ 肩部膠合間隙模具 K213287StageOne 適合膝關節水泥間隙模具 K212431比奧美特答桉/影響/整合遠端中心器/中心套管

查看所有 36 項裝置 →

相關器械（代碼：MBB）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K252443空間修復肩部間隔器G21, S.R.L.K242216GENTAFIX® (1, 3, 3MV)Teknimed Sas K240856臀部間隔模具；膝蓋間隔模具；肩膀間隔模具Osartis GmbH K221968StageOne™ 肩部膠合間隙模具Biomet, Inc.K213287StageOne 適合膝關節水泥間隙模具Biomet, Inc.K202338空間柔軟肩部設備G21, S.R.L.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。