FDA 510(k)

沃尔夫定律前颈椎板系统

K号: K240592 · 2024-05-24

决定日期2024-05-24

产品代码KWQ

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

Wolff's Law Anterior Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Simplicity, LLC. It received FDA 510(k) clearance on 2024-05-24 under 510(k) number K240592. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Wolff's Law Anterior Cervical Plate System?

Wolff's Law Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2024-05-24. The listed applicant is Spinal Simplicity, LLC. The 510(k) number is K240592.

When did Wolff's Law Anterior Cervical Plate System receive FDA 510(k) clearance?

Wolff's Law Anterior Cervical Plate System received FDA 510(k) clearance on 2024-05-24, under 510(k) number K240592.

Who is the listed applicant for Wolff's Law Anterior Cervical Plate System?

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

What is the FDA product code for Wolff's Law Anterior Cervical Plate System?

The FDA product code for Wolff's Law Anterior Cervical Plate System is KWQ.

列明Spinal Simplicity, LLC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。

K253250Minuteman® G6 MIS融合板 K250001Patriot SI植入系统 K232259Patriot-SI后植入系统 K234051Minuteman G5 MIS融合板；Minuteman G1（后融合板/HA后融合板）；HA Minuteman G3-R MIS融合板；Minuteman G3/HA Minuteman G3 K231923Liberty SI侧向植入系统 K233527Minuteman G5 MIS融合板；Minuteman G1（后融合板/HA后融合板）；HA Minuteman G3-R MIS融合板；Minuteman G3/HA Minuteman G3 MIS融合板

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官方来源

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