FDA 510(k)

LONGY Implant and LONGY-N Implant

K号: K241462 · 2025-02-11

决定日期2025-02-11

产品代码DZE

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决定实质等同

器械摘要

LONGY Implant and LONGY-N Implant is the device name listed in this FDA 510(k) record. The listed applicant is Noris Medical , Ltd.. It received FDA 510(k) clearance on 2025-02-11 under 510(k) number K241462. 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 LONGY Implant and LONGY-N Implant?

LONGY Implant and LONGY-N Implant is a medical device that received FDA 510(k) clearance on 2025-02-11. The listed applicant is Noris Medical , Ltd.. The 510(k) number is K241462.

When did LONGY Implant and LONGY-N Implant receive FDA 510(k) clearance?

LONGY Implant and LONGY-N Implant received FDA 510(k) clearance on 2025-02-11, under 510(k) number K241462.

Who is the listed applicant for LONGY Implant and LONGY-N Implant?

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

What is the FDA product code for LONGY Implant and LONGY-N Implant?

The FDA product code for LONGY Implant and LONGY-N Implant is DZE.

列明Noris Medical , Ltd.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。

K240202锥形平台牙种植系统 K210852Noris Medical牙科植入系统 - Cortical K210356Noris Medical牙科植入系统 K162308Noris Medical MBI-2mm牙科植入系统 K153043Noris Medical MBI牙科植入系统 K151909Noris Medical颧骨牙科植入系统

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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。