FDA 510(k)

PRAMA 白色植入系统

K号: K180365 · 2019-07-08

决定日期2019-07-08

产品代码DZE

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决定实质等同

器械摘要

PRAMA White Implant Systems is the device name listed in this FDA 510(k) record. The listed applicant is Sweden & Martina S.P.A.. It received FDA 510(k) clearance on 2019-07-08 under 510(k) number K180365. 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 PRAMA White Implant Systems?

PRAMA White Implant Systems is a medical device that received FDA 510(k) clearance on 2019-07-08. The listed applicant is Sweden & Martina S.P.A.. The 510(k) number is K180365.

When did PRAMA White Implant Systems receive FDA 510(k) clearance?

PRAMA White Implant Systems received FDA 510(k) clearance on 2019-07-08, under 510(k) number K180365.

Who is the listed applicant for PRAMA White Implant Systems?

The FDA 510(k) record lists Sweden & Martina S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRAMA White Implant Systems?

The FDA product code for PRAMA White Implant Systems is DZE.

列明Sweden & Martina S.P.A.为申报人的其他记录

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。

K222640Sweden & Martina Surgical Trays K182084Sweden & Martina Surgical Tray (Model ZSHORTY-INT)K161989PREMIUM植入系统SHELTA植入系统 K172560PREMIUM ONE植入系统 K162028PREMIUM - SHELTA假肢组件 K162004PREMIUM植入系统SHELTA植入系统

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官方来源

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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。