FDA 510(k)

Osteon 精密铣削上结构

K号: K221019 · 2022-07-05

申请人Implant Solutions Pty Ltd (Aka Osteon Medical)

决定日期2022-07-05

产品代码NHA

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决定实质等同

器械摘要

Osteon Precision Milled Suprastructure is the device name listed in this FDA 510(k) record. The listed applicant is Implant Solutions Pty Ltd (Aka Osteon Medical). It received FDA 510(k) clearance on 2022-07-05 under 510(k) number K221019. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Osteon Precision Milled Suprastructure?

Osteon Precision Milled Suprastructure is a medical device that received FDA 510(k) clearance on 2022-07-05. The listed applicant is Implant Solutions Pty Ltd (Aka Osteon Medical). The 510(k) number is K221019.

When did Osteon Precision Milled Suprastructure receive FDA 510(k) clearance?

Osteon Precision Milled Suprastructure received FDA 510(k) clearance on 2022-07-05, under 510(k) number K221019.

Who is the listed applicant for Osteon Precision Milled Suprastructure?

The FDA 510(k) record lists Implant Solutions Pty Ltd (Aka Osteon Medical) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Osteon Precision Milled Suprastructure?

The FDA product code for Osteon Precision Milled Suprastructure is NHA.

列明Implant Solutions Pty Ltd (Aka Osteon Medical)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。

K233083Osteon 精密铣削上结构

相关器械（代码：NHA）

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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