FDA 510(k)

REMEDY 去根膝蓋間隔系統，配備全塑質胫骨组件

K 號：K242377 · 2024-10-02

決定日期2024-10-02

產品代碼JWH

諮詢委員會或

決定相當於

器材摘要

REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component is the device name listed in this FDA 510(k) record. The listed applicant is Osteoremedies, LLC. It received FDA 510(k) clearance on 2024-10-02 under 510(k) number K242377. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component?

REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component is a medical device that received FDA 510(k) clearance on 2024-10-02. The listed applicant is Osteoremedies, LLC. The 510(k) number is K242377.

When did REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component receive FDA 510(k) clearance?

REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component received FDA 510(k) clearance on 2024-10-02, under 510(k) number K242377.

Who is the listed applicant for REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component?

FDA 510(k) 記錄中將 Osteoremedies, LLC 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component?

The FDA product code for REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component is JWH.

其他以 Osteoremedies, LLC 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。

K262290REMEDY POLY+PLUS 快速適合髋白杯 K253675骨修療股骨間隙系統 K250760SPECTRUM GV 骨水泥 K231556SPECTRUM® GV 骨水泥 K223650REMEDY 根除膝間隔離器 K192995骨修療股骨間隙系統

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相關器械（代碼：JWH）

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。

K262057GMK 扩充設備Medacta International SA K260063GSPE 分隔器The General Hospital Corporation, d/b/a Massachusetts K262293EVOLUTION MPX™ 全膝系統Suzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ 全膝系統修復水泥固定胫骨增強器、樹枝擴展和壓入式樹枝擴展B-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK膝關節系統Just Medical Devices (Tianjin) Co., Ltd.

官方來源

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