FDA 510(k)

Curiteva 椎板成形系统

K号: K231232 · 2023-06-28

决定日期2023-06-28

产品代码NQW

咨询委员会OR 请注意，由于原文中未提供具体的医疗设备监管文本，以下是一个示例翻译，您可以根据实际文本进行调整： --- 产品名称：[产品名称] 公司名称：[公司名称] 根据FDA 510(k)预市场批准程序，[产品名称]已获得批准，用于[产品用途描述]。产品注册号：[注册号] PMA编号：[PMA编号] 临床试验编号（NCT）：[NCT编号] PubMed ID（PMID）：[PMID编号] 更多信息请访问以下链接： [URL] --- 请将上述示例中的[产品名称]、[公司名称]、[注册号]、[PMA编号]、[NCT编号]、[PMID编号]和[URL]替换为实际的文本内容。

决定实质等同

器械摘要

Curiteva Laminoplasty System is the device name listed in this FDA 510(k) record. The listed applicant is Curiteva, Inc.. It received FDA 510(k) clearance on 2023-06-28 under 510(k) number K231232. The device is classified under product code NQW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Curiteva Laminoplasty System?

Curiteva Laminoplasty System is a medical device that received FDA 510(k) clearance on 2023-06-28. The listed applicant is Curiteva, Inc.. The 510(k) number is K231232.

When did Curiteva Laminoplasty System receive FDA 510(k) clearance?

Curiteva Laminoplasty System received FDA 510(k) clearance on 2023-06-28, under 510(k) number K231232.

Who is the listed applicant for Curiteva Laminoplasty System?

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

What is the FDA product code for Curiteva Laminoplasty System?

The FDA product code for Curiteva Laminoplasty System is NQW.

列明Curiteva, 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。

K252205Curiteva 多孔PEEK颈椎椎间系统；Curiteva 多孔PEEK腰椎椎间融合系统；Curiteva 多孔PEEK椎板成形系统；Curiteva 多孔PEEK独立ALIF系统 K254061Curiteva 多孔PEEK颈椎椎间融合系统 K250845Curiteva 多孔PEEK独立ALIF系统 K243137Curiteva 多孔PEEK椎板成形系统 K233360Curiteva 胸腰椎板系统 K233744Curiteva 多孔PEEK腰椎椎间融合系统

查看所有 11 个设备 →

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。