FDA 510(k)

SpaceFlex 髋臼杯

K 號：K223441 · 2023-03-23

決定日期2023-03-23

產品代碼KWY

諮詢委員會或

決定相當於

器材摘要

SpaceFlex Acetabular Cup 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 2023-03-23 under 510(k) number K223441. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SpaceFlex Acetabular Cup?

SpaceFlex Acetabular Cup is a medical device that received FDA 510(k) clearance on 2023-03-23. The listed applicant is G21, S.R.L.. The 510(k) number is K223441.

When did SpaceFlex Acetabular Cup receive FDA 510(k) clearance?

SpaceFlex Acetabular Cup received FDA 510(k) clearance on 2023-03-23, under 510(k) number K223441.

Who is the listed applicant for SpaceFlex Acetabular Cup?

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 Acetabular Cup?

The FDA product code for SpaceFlex Acetabular Cup is KWY.

其他以 G21, S.R.L. 為申請人之記錄

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K252443空間修復肩部間隔器 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：KWY）

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。

K253357b-ONE®雙極頭B-One Ortho, Corp.K243634Maxx Libertas雙極股頭 (雙極股)Maxx Orthopedics, Inc.K231526CORAIL Cemented Femoral StemDepuy Ireland UC K221794Vario-Cup 系統Waldemar Link GmbH & Co. KG K220492COPAL交換G 髋間隔離器Heraeus Medical GmbH K200709京瓷雙極股骨系統Kyocera Medical Technologies, Inc.

官方來源

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