FDA 510(k)

EASYMADE-TI

K号: K252251 · 2026-04-09

决定日期2026-04-09

产品代码GXN

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决定实质等同

器械摘要

EASYMADE-TI is the device name listed in this FDA 510(k) record. The listed applicant is CG Bio Co., Ltd.. It received FDA 510(k) clearance on 2026-04-09 under 510(k) number K252251. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EASYMADE-TI?

EASYMADE-TI is a medical device that received FDA 510(k) clearance on 2026-04-09. The listed applicant is CG Bio Co., Ltd.. The 510(k) number is K252251.

When did EASYMADE-TI receive FDA 510(k) clearance?

EASYMADE-TI received FDA 510(k) clearance on 2026-04-09, under 510(k) number K252251.

Who is the listed applicant for EASYMADE-TI?

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

What is the FDA product code for EASYMADE-TI?

The FDA product code for EASYMADE-TI is GXN.

列明CG Bio Co., 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。

K253199CURASYS 2 (EMDN0003)K250582COLONNADE后部螺钉固定系统 K222229高级LumFix脊柱固定系统 K160731LumFix脊柱固定系统

相关器械（代码：GXN）

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。

K260709ClearFit Ti 环 14mm (171750)；ClearFit Ti 环 14mm 带槽 (171751)；ClearFit Ti 环 20mm (171752)；ClearFit Ti 环 20mm 带槽 (171753)；ClearFit Ti 环 30mm (171754)Longeviti Neuro Solutions K2531163D MAC 钛颅骨板 (TCP) 系统The Surgeon General, Department of the Army (TSG-DA)K252958METICULY 定制钛网状植入物Meticuly Co., Ltd.K243715Synthes患者特异性植入物Synthes GmbH K252573KLS Martin 颅骨植入物 - MR 条件；K944565：KLS-Martin 微型骨合成系统（1.5MM）；K971297：KLS Martin 中心驱动无钻螺丝；K060177：KLS Martin 刚性固定 - 无菌；K062570：个体化患者解决方案 - Ti (IPS-Ti)；K072707：个体化患者解决方案 - PEEK (IPS-PEEK)；K151382：个体化患者解决方案 - (IPS-PEEK) - 无菌KLS-Martin L.P.K240567定制骨服务Fin-Ceramica Faenza S.P.A.

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