Adaptix Ortho350
K号: K252133 · 2025-11-06
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器械摘要
Adaptix Ortho350 is the device name listed in this FDA 510(k) record. The listed applicant is Adaptix Limited. It received FDA 510(k) clearance on 2025-11-06 under 510(k) number K252133. The device is classified under product code IZF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Adaptix Ortho350?
Adaptix Ortho350 is a medical device that received FDA 510(k) clearance on 2025-11-06. The listed applicant is Adaptix Limited. The 510(k) number is K252133.
When did Adaptix Ortho350 receive FDA 510(k) clearance?
Adaptix Ortho350 received FDA 510(k) clearance on 2025-11-06, under 510(k) number K252133.
Who is the listed applicant for Adaptix Ortho350?
The FDA 510(k) record lists Adaptix Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Adaptix Ortho350?
The FDA product code for Adaptix Ortho350 is IZF.
相关临床试验
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相关器械（代码：IZF）
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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