FDA 510(k)

BoneTrust植入系统

K号: K182313 · 2019-03-11

决定日期2019-03-11

产品代码DZE

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决定实质等同

器械摘要

BoneTrust Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Medical Instinct Deutschland GmbH. It received FDA 510(k) clearance on 2019-03-11 under 510(k) number K182313. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BoneTrust Implant System?

BoneTrust Implant System is a medical device that received FDA 510(k) clearance on 2019-03-11. The listed applicant is Medical Instinct Deutschland GmbH. The 510(k) number is K182313.

When did BoneTrust Implant System receive FDA 510(k) clearance?

BoneTrust Implant System received FDA 510(k) clearance on 2019-03-11, under 510(k) number K182313.

Who is the listed applicant for BoneTrust Implant System?

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

What is the FDA product code for BoneTrust Implant System?

The FDA product code for BoneTrust Implant System is DZE.

列明Medical Instinct Deutschland GmbH为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K200573BoneTrust迷你植入系统

官方来源

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