FDA 510(k)

PALACOS 快速 R+G

K 號：K190766 · 2019-05-31

決定日期2019-05-31

產品代碼LOD

諮詢委員會或

決定相當於

器材摘要

PALACOS fast R+G is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Medical GmbH. It received FDA 510(k) clearance on 2019-05-31 under 510(k) number K190766. 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 PALACOS fast R+G?

PALACOS fast R+G is a medical device that received FDA 510(k) clearance on 2019-05-31. The listed applicant is Heraeus Medical GmbH. The 510(k) number is K190766.

When did PALACOS fast R+G receive FDA 510(k) clearance?

PALACOS fast R+G received FDA 510(k) clearance on 2019-05-31, under 510(k) number K190766.

Who is the listed applicant for PALACOS fast R+G?

The FDA 510(k) record lists Heraeus Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PALACOS fast R+G?

The FDA product code for PALACOS fast R+G is LOD.

其他以 Heraeus Medical GmbH 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。

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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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