FDA 510(k)

Bonalive 骨科藥品粉末

K 號：K231528 · 2023-07-11

決定日期2023-07-11

產品代碼MQV

諮詢委員會或

決定相當於

器材摘要

Bonalive Orthopedics granules is the device name listed in this FDA 510(k) record. The listed applicant is Bonalive Biomaterials, Ltd.. It received FDA 510(k) clearance on 2023-07-11 under 510(k) number K231528. 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 Bonalive Orthopedics granules?

Bonalive Orthopedics granules is a medical device that received FDA 510(k) clearance on 2023-07-11. The listed applicant is Bonalive Biomaterials, Ltd.. The 510(k) number is K231528.

When did Bonalive Orthopedics granules receive FDA 510(k) clearance?

Bonalive Orthopedics granules received FDA 510(k) clearance on 2023-07-11, under 510(k) number K231528.

Who is the listed applicant for Bonalive Orthopedics granules?

The FDA 510(k) record lists Bonalive Biomaterials, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bonalive Orthopedics granules?

The FDA product code for Bonalive Orthopedics granules is MQV.

其他以 Bonalive Biomaterials, Ltd. 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。

K191274BonAlive 粉末

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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