INOSS 系统
K号: K260006 · 2026-06-17
广告
申请人Inosys, Inc.
决定日期2026-06-17
产品代码DZE
咨询委员会DE
请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。
决定实质等同
器械摘要
INOSS System is the device name listed in this FDA 510(k) record. The listed applicant is Inosys, Inc.. It received FDA 510(k) clearance on 2026-06-17 under 510(k) number K260006. 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 INOSS System?
INOSS System is a medical device that received FDA 510(k) clearance on 2026-06-17. The listed applicant is Inosys, Inc.. The 510(k) number is K260006.
When did INOSS System receive FDA 510(k) clearance?
INOSS System received FDA 510(k) clearance on 2026-06-17, under 510(k) number K260006.
Who is the listed applicant for INOSS System?
The FDA 510(k) record lists Inosys, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for INOSS System?
The FDA product code for INOSS System is DZE.
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：DZE）
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。
K261392TriActive 牙齿种植系统Paragon Implant Mfg., LLCK260463ZEROS 牙齿种植系统Zeros Co., Ltd.K251188UNIQA® 牙齿种植系统Uniqa Dental, Ltd.K251232MegaGen颧骨牙科植入系统Megagen Implant Co., Ltd.K250806牙科植入系统A.B. Dental Devices , Ltd.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic AB
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。
广告