FDA 510(k)

TECHFIT 患者专用颅骨系统

K号: K250297 · 2025-10-27

决定日期2025-10-27

产品代码GWO

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

TECHFIT Patient-Specific Cranial System is the device name listed in this FDA 510(k) record. The listed applicant is Techfit Digital Surgery, Inc.. It received FDA 510(k) clearance on 2025-10-27 under 510(k) number K250297. 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 TECHFIT Patient-Specific Cranial System?

TECHFIT Patient-Specific Cranial System is a medical device that received FDA 510(k) clearance on 2025-10-27. The listed applicant is Techfit Digital Surgery, Inc.. The 510(k) number is K250297.

When did TECHFIT Patient-Specific Cranial System receive FDA 510(k) clearance?

TECHFIT Patient-Specific Cranial System received FDA 510(k) clearance on 2025-10-27, under 510(k) number K250297.

Who is the listed applicant for TECHFIT Patient-Specific Cranial System?

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

What is the FDA product code for TECHFIT Patient-Specific Cranial System?

The FDA product code for TECHFIT Patient-Specific Cranial System is GWO.

列明Techfit Digital Surgery, 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。

K242263TECHFIT DISRP® 系统 K222577TECHFIT 诊断模型 K220199AFFINITY 近端胫骨系统

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 K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, 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

在 FDA 数据库中查看 →

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。