FDA 510(k)

外部六角植入系统

K号: K232726 · 2024-04-01

决定日期2024-04-01

产品代码DZE

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决定实质等同

器械摘要

External Hex Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Southern Implants (Pty), Ltd.. It received FDA 510(k) clearance on 2024-04-01 under 510(k) number K232726. 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 External Hex Implant System?

External Hex Implant System is a medical device that received FDA 510(k) clearance on 2024-04-01. The listed applicant is Southern Implants (Pty), Ltd.. The 510(k) number is K232726.

When did External Hex Implant System receive FDA 510(k) clearance?

External Hex Implant System received FDA 510(k) clearance on 2024-04-01, under 510(k) number K232726.

Who is the listed applicant for External Hex Implant System?

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

What is the FDA product code for External Hex Implant System?

The FDA product code for External Hex Implant System is DZE.

列明Southern Implants (Pty), 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。

K232418单平台SP1植入系统 K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments K222469TIB连接体 K222457Provata 假体系统 K222497Zaga颧骨系统 K210923Southern 器械工具托盘

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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。