FDA 510(k)

SPECTRUM® GV 骨水泥

K 號：K231556 · 2023-12-20

決定日期2023-12-20

產品代碼LOD

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決定相當於

器材摘要

SPECTRUM® GV 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 2023-12-20 under 510(k) number K231556. The device is classified under product code LOD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SPECTRUM® GV Bone Cement?

SPECTRUM® GV Bone Cement is a medical device that received FDA 510(k) clearance on 2023-12-20. The listed applicant is Osteoremedies, LLC. The 510(k) number is K231556.

When did SPECTRUM® GV Bone Cement receive FDA 510(k) clearance?

SPECTRUM® GV Bone Cement received FDA 510(k) clearance on 2023-12-20, under 510(k) number K231556.

Who is the listed applicant for SPECTRUM® GV 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 SPECTRUM® GV Bone Cement?

The FDA product code for SPECTRUM® GV Bone Cement is LOD.

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 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：LOD）

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。

K254107Refobacin骨水泥R (110034355)Biomet France K250760SPECTRUM GV 骨水泥Osteoremedies, LLC K241674OSTEOPAL® VHeraeus Medical GmbH K211163骨水泥Genta，骨水泥HV，骨水泥LVTecres S.P.A.K212729骨水泥-正常濃度Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda K211869OGM 1 聚甲基丙烯酸甲酯（PMMA）骨水泥，OGM 1A 聚甲基丙烯酸甲酯（PMMA）骨水泥Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE

官方來源

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