OsteoSight™ 髋关节 (v1)
K号: K251408 · 2025-09-02
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器械摘要
OsteoSight™ Hip (v1) is the device name listed in this FDA 510(k) record. The listed applicant is Naitive Technologies, Ltd.. It received FDA 510(k) clearance on 2025-09-02 under 510(k) number K251408. The device is classified under product code SAO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OsteoSight™ Hip (v1)?
OsteoSight™ Hip (v1) is a medical device that received FDA 510(k) clearance on 2025-09-02. The listed applicant is Naitive Technologies, Ltd.. The 510(k) number is K251408.
When did OsteoSight™ Hip (v1) receive FDA 510(k) clearance?
OsteoSight™ Hip (v1) received FDA 510(k) clearance on 2025-09-02, under 510(k) number K251408.
Who is the listed applicant for OsteoSight™ Hip (v1)?
The FDA 510(k) record lists Naitive Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OsteoSight™ Hip (v1)?
The FDA product code for OsteoSight™ Hip (v1) is SAO.
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：SAO）
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。
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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