FDA 510(k)

PAHALOS MV pro

K 號：K213812 · 2022-02-02

決定日期2022-02-02

產品代碼LOD

諮詢委員會或

決定相當於

器材摘要

PALACOS MV pro 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 2022-02-02 under 510(k) number K213812. 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 MV pro?

PALACOS MV pro is a medical device that received FDA 510(k) clearance on 2022-02-02. The listed applicant is Heraeus Medical GmbH. The 510(k) number is K213812.

When did PALACOS MV pro receive FDA 510(k) clearance?

PALACOS MV pro received FDA 510(k) clearance on 2022-02-02, under 510(k) number K213812.

Who is the listed applicant for PALACOS MV pro?

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 MV pro?

The FDA product code for PALACOS MV pro 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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