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FDA 510(k)

FORTIS 和 HANA 前路颈椎板系统，Rex 前路颈椎板系统，以及 BALTEUM™ & BALTEUM-ONE™ 腰椎板系统

K号: K222572 · 2022-10-18

申请人Dio Medical Corporation
决定日期2022-10-18
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

FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Dio Medical Corporation. It received FDA 510(k) clearance on 2022-10-18 under 510(k) number K222572. 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 FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System?

FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System is a medical device that received FDA 510(k) clearance on 2022-10-18. The listed applicant is Dio Medical Corporation. The 510(k) number is K222572.

When did FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System receive FDA 510(k) clearance?

FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System received FDA 510(k) clearance on 2022-10-18, under 510(k) number K222572.

Who is the listed applicant for FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System?

The FDA 510(k) record lists Dio Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System?

The FDA product code for FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System is KWQ.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Dio Medical Corporation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。

K222415Rexious脊柱固定系统K222448UNITY 骶髂关节固定系统K222515FaSet 固定系统

相关器械（代码：KWQ）

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。

K262149corra®颈椎钢板系统Carlsmed, Inc.K261309Palisades™ 桥墩板系统Bethesda Medical Devices, LLCK252776ARIES 前颈椎板系统ZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P 前颈部板系统L&K BIOMED Co., Ltd.K260570corra™颈椎钢板系统Carlsmed, Inc.K260697VyPlate™ 颈前钢板系统Vy Spine, LLC

官方来源

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