FDA 510(k)

切割螺钉 - 经皮压缩螺钉

K号: K230397 · 2023-06-12

申请人GM Dos Reis Industria e Comercio Ltda.

决定日期2023-06-12

产品代码HWC

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

Cut Screw - Percutaneous Compression Screw is the device name listed in this FDA 510(k) record. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. It received FDA 510(k) clearance on 2023-06-12 under 510(k) number K230397. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the Cut Screw - Percutaneous Compression Screw?

Cut Screw - Percutaneous Compression Screw is a medical device that received FDA 510(k) clearance on 2023-06-12. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. The 510(k) number is K230397.

When did Cut Screw - Percutaneous Compression Screw receive FDA 510(k) clearance?

Cut Screw - Percutaneous Compression Screw received FDA 510(k) clearance on 2023-06-12, under 510(k) number K230397.

Who is the listed applicant for Cut Screw - Percutaneous Compression Screw?

FDA 510(k)记录将GM Dos Reis Industria e Comercio Ltda.列为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for Cut Screw - Percutaneous Compression Screw?

The FDA product code for Cut Screw - Percutaneous Compression Screw is HWC. This falls under the Cardiovascular category.

列明GM Dos Reis Industria e Comercio Ltda.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。

K253910Stitch - 缝线钢丝和胶带 K262537Versalock无菌敷贴系统 K261406Versalock 近端胫骨接骨板系统 K260390超级上肢Versalock接骨板系统 K254188Meniscus Versaflex K252664GMReis 缝合锚

查看所有 16 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。