FDA 510(k)

G3A 40 骨水泥

K 號：K181282 · 2019-01-09

決定日期2019-01-09

產品代碼LOD

諮詢委員會或

決定相當於

器材摘要

G3A 40 Bone Cement 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 2019-01-09 under 510(k) number K181282. 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 G3A 40 Bone Cement?

G3A 40 Bone Cement is a medical device that received FDA 510(k) clearance on 2019-01-09. The listed applicant is G21, S.R.L.. The 510(k) number is K181282.

When did G3A 40 Bone Cement receive FDA 510(k) clearance?

G3A 40 Bone Cement received FDA 510(k) clearance on 2019-01-09, under 510(k) number K181282.

Who is the listed applicant for G3A 40 Bone Cement?

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 G3A 40 Bone Cement?

The FDA product code for G3A 40 Bone Cement is LOD.

其他以 G21, S.R.L. 為申請人之記錄

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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 K231556SPECTRUM® GV 骨水泥Osteoremedies, LLC 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

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