FDA 510(k)

引导手术套件

K号: K231087 · 2023-08-16

申请人Implant Direct Sybron Manufacturing, LLC

决定日期2023-08-16

产品代码DZI

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决定实质等同

器械摘要

Guided Surgery Kit is the device name listed in this FDA 510(k) record. The listed applicant is Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2023-08-16 under 510(k) number K231087. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Guided Surgery Kit?

Guided Surgery Kit is a medical device that received FDA 510(k) clearance on 2023-08-16. The listed applicant is Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K231087.

When did Guided Surgery Kit receive FDA 510(k) clearance?

Guided Surgery Kit received FDA 510(k) clearance on 2023-08-16, under 510(k) number K231087.

Who is the listed applicant for Guided Surgery Kit?

The FDA 510(k) record lists Implant Direct Sybron Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Guided Surgery Kit?

The FDA product code for Guided Surgery Kit is DZI.

列明Implant Direct Sybron Manufacturing, LLC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。

K223535SMARTbase 牙槽基台系统 K222211Implant Direct 牙齿植入系统组合 - MR 条件 K202524标准可灭菌托盘 K201553Simply Iconic Implants K200858微型可灭菌托盘 K200265Surgical Drills

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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。