FDA 510(k)

REMEDY 根除膝間隔離器

K 號：K223650 · 2023-01-05

決定日期2023-01-05

產品代碼JWH

諮詢委員會或

決定相當於

器材摘要

REMEDY Stemmed Knee Spacer is the device name listed in this FDA 510(k) record. The listed applicant is Osteoremedies, LLC. It received FDA 510(k) clearance on 2023-01-05 under 510(k) number K223650. 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?

REMEDY Stemmed Knee Spacer is a medical device that received FDA 510(k) clearance on 2023-01-05. The listed applicant is Osteoremedies, LLC. The 510(k) number is K223650.

When did REMEDY Stemmed Knee Spacer receive FDA 510(k) clearance?

REMEDY Stemmed Knee Spacer received FDA 510(k) clearance on 2023-01-05, under 510(k) number K223650.

Who is the listed applicant for REMEDY Stemmed Knee Spacer?

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?

The FDA product code for REMEDY Stemmed Knee Spacer 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 K242377REMEDY 去根膝蓋間隔系統，配備全塑質胫骨组件 K231556SPECTRUM® GV 骨水泥 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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