FDA 510(k)

VSP PEEK 颅骨植入物

K号: K231834 · 2024-04-04

决定日期2024-04-04

产品代码GWO

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决定实质等同

器械摘要

VSP PEEK Cranial Implant is the device name listed in this FDA 510(k) record. The listed applicant is 3D Systems, Inc.. It received FDA 510(k) clearance on 2024-04-04 under 510(k) number K231834. 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 VSP PEEK Cranial Implant?

VSP PEEK Cranial Implant is a medical device that received FDA 510(k) clearance on 2024-04-04. The listed applicant is 3D Systems, Inc.. The 510(k) number is K231834.

When did VSP PEEK Cranial Implant receive FDA 510(k) clearance?

VSP PEEK Cranial Implant received FDA 510(k) clearance on 2024-04-04, under 510(k) number K231834.

Who is the listed applicant for VSP PEEK Cranial Implant?

The FDA 510(k) record lists 3D Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VSP PEEK Cranial Implant?

The FDA product code for VSP PEEK Cranial Implant is GWO.

列明3D Systems, 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。

K261826VSP系统（钛聘弓）K250711VSP骨科系统 K243174Cadence Ankle PSI System K243173Salto Talaris踝关节PSI系统 K241326Cadence Ankle PSI System K241148Salto Talaris踝关节PSI系统

查看所有 12 个设备 →

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.K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, 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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