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FDA 510(k)

骨水泥-正常濃度

K 號:K212729 · 2022-05-31

決定日期2022-05-31
產品代碼LOD
諮詢委員會或
決定相當於

器材摘要

Bone Cement-Normal Viscosity is the device name listed in this FDA 510(k) record. The listed applicant is Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda. It received FDA 510(k) clearance on 2022-05-31 under 510(k) number K212729. 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 Bone Cement-Normal Viscosity?

Bone Cement-Normal Viscosity is a medical device that received FDA 510(k) clearance on 2022-05-31. The listed applicant is Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda. The 510(k) number is K212729.

When did Bone Cement-Normal Viscosity receive FDA 510(k) clearance?

Bone Cement-Normal Viscosity received FDA 510(k) clearance on 2022-05-31, under 510(k) number K212729.

Who is the listed applicant for Bone Cement-Normal Viscosity?

The FDA 510(k) record lists Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bone Cement-Normal Viscosity?

The FDA product code for Bone Cement-Normal Viscosity is LOD.

相關臨床試驗

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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。

官方來源

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