DTI-1 SLA 内固定系统
K号: K170776 · 2018-04-10
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决定日期2018-04-10
产品代码DZE
咨询委员会DE
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决定实质等同
器械摘要
DTI-1 SLA IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi. It received FDA 510(k) clearance on 2018-04-10 under 510(k) number K170776. 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 DTI-1 SLA IMPLANT SYSTEM?
DTI-1 SLA IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2018-04-10. The listed applicant is Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi. The 510(k) number is K170776.
When did DTI-1 SLA IMPLANT SYSTEM receive FDA 510(k) clearance?
DTI-1 SLA IMPLANT SYSTEM received FDA 510(k) clearance on 2018-04-10, under 510(k) number K170776.
Who is the listed applicant for DTI-1 SLA IMPLANT SYSTEM?
The FDA 510(k) record lists Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DTI-1 SLA IMPLANT SYSTEM?
The FDA product code for DTI-1 SLA IMPLANT SYSTEM is DZE.
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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。
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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