FDA 510(k)

Fusion Craniofacial Implant; Fusion Skull Implant

K号: K250334 · 2025-07-25

决定日期2025-07-25

产品代码GWO

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决定实质等同

器械摘要

Fusion Craniofacial Implant; Fusion Skull Implant is the device name listed in this FDA 510(k) record. The listed applicant is Kelyniam Global, Inc.. It received FDA 510(k) clearance on 2025-07-25 under 510(k) number K250334. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Fusion Craniofacial Implant; Fusion Skull Implant?

Fusion Craniofacial Implant; Fusion Skull Implant is a medical device that received FDA 510(k) clearance on 2025-07-25. The listed applicant is Kelyniam Global, Inc.. The 510(k) number is K250334.

When did Fusion Craniofacial Implant; Fusion Skull Implant receive FDA 510(k) clearance?

Fusion Craniofacial Implant; Fusion Skull Implant received FDA 510(k) clearance on 2025-07-25, under 510(k) number K250334.

Who is the listed applicant for Fusion Craniofacial Implant; Fusion Skull Implant?

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

What is the FDA product code for Fusion Craniofacial Implant; Fusion Skull Implant?

The FDA product code for Fusion Craniofacial Implant; Fusion Skull Implant is GWO.

列明Kelyniam Global, 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。

K182711定制颅面植入物（CCI），定制颅骨植入物（CSI）

相关器械（代码：GWO）

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。

K262874颅部US板CraniUS, LLC K261058颅部US板CraniUS, LLC K250297TECHFIT 患者专用颅骨系统Techfit Digital Surgery, Inc.K231834VSP PEEK 颅骨植入物3D Systems, Inc.K212391MCI-Neuro 固定系统Mci Medical Concept Innovation, Inc.K210360Neuro Plating 系统, Neuro Plating 系统板 (NST304M02A 和 61 型号), Neuro Plating 系统-包装单元 (NSP-001 和 10 型号), Neuro Plating 系统-无菌套件 (TCN-011 和 69 型号), Neuro Plating 系统-螺丝 (N15A03 和 11 型号)Osteonic Co., Ltd.

官方来源

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