FDA 510(k)

EK D3.3 和超宽植入物

K号: K240232 · 2024-09-13

决定日期2024-09-13

产品代码DZE

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决定实质等同

器械摘要

EK D3.3 and Ultra Wide Implants is the device name listed in this FDA 510(k) record. The listed applicant is Hiossen, Inc.. It received FDA 510(k) clearance on 2024-09-13 under 510(k) number K240232. 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 EK D3.3 and Ultra Wide Implants?

EK D3.3 and Ultra Wide Implants is a medical device that received FDA 510(k) clearance on 2024-09-13. The listed applicant is Hiossen, Inc.. The 510(k) number is K240232.

When did EK D3.3 and Ultra Wide Implants receive FDA 510(k) clearance?

EK D3.3 and Ultra Wide Implants received FDA 510(k) clearance on 2024-09-13, under 510(k) number K240232.

Who is the listed applicant for EK D3.3 and Ultra Wide Implants?

The FDA 510(k) record lists Hiossen, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EK D3.3 and Ultra Wide Implants?

The FDA product code for EK D3.3 and Ultra Wide Implants is DZE.

列明Hiossen, Inc.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。

K253372ET修复连接体；ET扫描修复连接体；EK扫描修复连接体 K251427EK MULTI ANGLED 30 基台 K241003HIOSSEN 预加工基台（ET 预加工基台 & EK 预加工基台）K233389EK 数字基台 K222636ET连接体系统 K203360EK 植入物和基台系统

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官方来源

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