Osteon 精密铣削上结构
K号: K212676 · 2022-03-03
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决定日期2022-03-03
产品代码NHA
咨询委员会DE
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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 (Osteon Medical). It received FDA 510(k) clearance on 2022-03-03 under 510(k) number K212676. 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 2022-03-03. The listed applicant is Implant Solutions Pty Ltd (Osteon Medical). The 510(k) number is K212676.
When did Osteon Precision Milled Suprastructure receive FDA 510(k) clearance?
Osteon Precision Milled Suprastructure received FDA 510(k) clearance on 2022-03-03, under 510(k) number K212676.
Who is the listed applicant for Osteon Precision Milled Suprastructure?
The FDA 510(k) record lists Implant Solutions Pty Ltd (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.
相关临床试验
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。
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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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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