FDA 510(k)

StageOne一次性半肩臥式假肢水泥間隔模具

K 號：K160071 · 2016-06-16

決定日期2016-06-16

產品代碼MBB

諮詢委員會或

決定相當於

器材摘要

StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2016-06-16 under 510(k) number K160071. 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 Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis?

StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis is a medical device that received FDA 510(k) clearance on 2016-06-16. The listed applicant is Biomet, Inc.. The 510(k) number is K160071.

When did StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis receive FDA 510(k) clearance?

StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis received FDA 510(k) clearance on 2016-06-16, under 510(k) number K160071.

Who is the listed applicant for StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis?

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 Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis?

The FDA product code for StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis 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）K222760StageOne™ 選擇式髋關節水泥間隔模具 K221968StageOne™ 肩部膠合間隙模具 K213287StageOne 適合膝關節水泥間隙模具

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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 K222760StageOne™ 選擇式髋關節水泥間隔模具Biomet, Inc.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.

官方來源

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