FDA 510(k)

Surgikor 固定一体，基桩空白和基桩

K号: K240803 · 2024-09-12

决定日期2024-09-12

产品代码DZE

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决定实质等同

器械摘要

Surgikor Fixation One, Abutment Blanks and Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Surgikor, LLC. It received FDA 510(k) clearance on 2024-09-12 under 510(k) number K240803. 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 Surgikor Fixation One, Abutment Blanks and Abutments?

Surgikor Fixation One, Abutment Blanks and Abutments is a medical device that received FDA 510(k) clearance on 2024-09-12. The listed applicant is Surgikor, LLC. The 510(k) number is K240803.

When did Surgikor Fixation One, Abutment Blanks and Abutments receive FDA 510(k) clearance?

Surgikor Fixation One, Abutment Blanks and Abutments received FDA 510(k) clearance on 2024-09-12, under 510(k) number K240803.

Who is the listed applicant for Surgikor Fixation One, Abutment Blanks and Abutments?

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

What is the FDA product code for Surgikor Fixation One, Abutment Blanks and Abutments?

The FDA product code for Surgikor Fixation One, Abutment Blanks and Abutments is DZE.

列明Surgikor, LLC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。

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官方来源

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