FDA 510(k)

空間修復肩部間隔器

K 號：K252443 · 2025-09-15

決定日期2025-09-15

產品代碼MBB

諮詢委員會或

決定相當於

器材摘要

SpaceFix Shoulder Spacer 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 2025-09-15 under 510(k) number K252443. 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 SpaceFix Shoulder Spacer?

SpaceFix Shoulder Spacer is a medical device that received FDA 510(k) clearance on 2025-09-15. The listed applicant is G21, S.R.L.. The 510(k) number is K252443.

When did SpaceFix Shoulder Spacer receive FDA 510(k) clearance?

SpaceFix Shoulder Spacer received FDA 510(k) clearance on 2025-09-15, under 510(k) number K252443.

Who is the listed applicant for SpaceFix Shoulder Spacer?

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 SpaceFix Shoulder Spacer?

The FDA product code for SpaceFix Shoulder Spacer 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。

K223441SpaceFlex 髋臼杯 K202338空間柔軟肩部設備 K201960SpaceFlex膝關節 - 80mm尺寸 K193061G3 40 鑫光顯影骨水泥 K193059G1 40 放射性不透骨水泥 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。

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.K202338空間柔軟肩部設備G21, S.R.L.

官方來源

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