FDA 510(k)

DB-EZ 骨空洞填充物

K 號：K212353 · 2021-09-22

決定日期2021-09-22

產品代碼MQV

諮詢委員會或

決定相當於

器材摘要

DB-EZ Bone Void Filler is the device name listed in this FDA 510(k) record. The listed applicant is Dimensional Bioceramics, LLC. It received FDA 510(k) clearance on 2021-09-22 under 510(k) number K212353. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DB-EZ Bone Void Filler?

DB-EZ Bone Void Filler is a medical device that received FDA 510(k) clearance on 2021-09-22. The listed applicant is Dimensional Bioceramics, LLC. The 510(k) number is K212353.

When did DB-EZ Bone Void Filler receive FDA 510(k) clearance?

DB-EZ Bone Void Filler received FDA 510(k) clearance on 2021-09-22, under 510(k) number K212353.

Who is the listed applicant for DB-EZ Bone Void Filler?

The FDA 510(k) record lists Dimensional Bioceramics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DB-EZ Bone Void Filler?

The FDA product code for DB-EZ Bone Void Filler is MQV.

其他以 Dimensional Bioceramics, 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。

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相關器械（代碼：MQV）

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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