FDA 510(k)

SpaceFlex膝關節 - 80mm尺寸

K 號：K201960 · 2020-08-13

決定日期2020-08-13

產品代碼MBB

諮詢委員會或

決定相當於

器材摘要

SpaceFlex Knee - 80mm Size is the device name listed in this FDA 510(k) record. The listed applicant is G21, S.R.L.. It received FDA 510(k) clearance on 2020-08-13 under 510(k) number K201960. 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 SpaceFlex Knee - 80mm Size?

SpaceFlex Knee - 80mm Size is a medical device that received FDA 510(k) clearance on 2020-08-13. The listed applicant is G21, S.R.L.. The 510(k) number is K201960.

When did SpaceFlex Knee - 80mm Size receive FDA 510(k) clearance?

SpaceFlex Knee - 80mm Size received FDA 510(k) clearance on 2020-08-13, under 510(k) number K201960.

Who is the listed applicant for SpaceFlex Knee - 80mm Size?

The FDA 510(k) record lists G21, S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SpaceFlex Knee - 80mm Size?

The FDA product code for SpaceFlex Knee - 80mm Size is MBB.

其他以 G21, S.R.L. 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。

K252443空間修復肩部間隔器 K223441SpaceFlex 髋臼杯 K202338空間柔軟肩部設備 K193059G1 40 放射性不透骨水泥 K193061G3 40 鑫光顯影骨水泥 K192041G21 空間柔軟骨盤

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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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