FDA 510(k)

REMEDY PLUS 髋關節間隔器，UNITE PLUS 骨水泥

K 號：K172906 · 2018-08-29

決定日期2018-08-29

產品代碼KWL

諮詢委員會或

決定相當於

器材摘要

REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement is the device name listed in this FDA 510(k) record. The listed applicant is Osteoremedies, LLC. It received FDA 510(k) clearance on 2018-08-29 under 510(k) number K172906. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement?

REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement is a medical device that received FDA 510(k) clearance on 2018-08-29. The listed applicant is Osteoremedies, LLC. The 510(k) number is K172906.

When did REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement receive FDA 510(k) clearance?

REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement received FDA 510(k) clearance on 2018-08-29, under 510(k) number K172906.

Who is the listed applicant for REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement?

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 PLUS Hip Spacer, UNITE PLUS Bone Cement?

The FDA product code for REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement is KWL.

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 K223650REMEDY 根除膝間隔離器

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相關器械（代碼：KWL）

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Osteoremedies, LLC K260536Prostalac 髋關節系統，SmartSet V+G雙抗生素骨水泥Depuy Ireland UC K253675骨修療股骨間隙系統Osteoremedies, LLC K252326InterSpace GV 髋關節間隔器Tecres S.P.A.K242865Synicem 髋關節間隔器；Synicem 開節間隔器；Synicem 肩關節間隔器Biocomposites, Ltd.K234028COPAL®交換G股間隔器；COPAL®G+VHeraeus Medical GmbH

官方來源

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