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FDA 510(k)

Accelerate 压缩螺钉系统-小产品代码 ACC-S；Accelerate 压缩螺钉系统-中产品代码 ACC-M；Accelerate 压缩螺钉系统-大产品代码 ACC-L

K号: K230946 · 2023-09-15

申请人Trax Surgical
决定日期2023-09-15
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

Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L is the device name listed in this FDA 510(k) record. The listed applicant is Trax Surgical. It received FDA 510(k) clearance on 2023-09-15 under 510(k) number K230946. 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 Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L?

Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L is a medical device that received FDA 510(k) clearance on 2023-09-15. The listed applicant is Trax Surgical. The 510(k) number is K230946.

When did Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L receive FDA 510(k) clearance?

Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L received FDA 510(k) clearance on 2023-09-15, under 510(k) number K230946.

Who is the listed applicant for Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L?

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

What is the FDA product code for Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L?

The FDA product code for Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L is HWC. This falls under the Cardiovascular category.

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Trax Surgical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。

K250712Linkt 压缩钉系统

相关器械（代码：HWC）

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。

K262975Arthrex Beaming系统Arthrex, Inc.K260995DynaNail螺旋®固定系统MedShape, Inc.K254280F.A.S.T. 螺丝Steps OrthoK261057ActivaScrew™ 穿刺式 COMBioretec, Ltd.K260106OsteoCoil™ GT 活动压缩系统Flower Orthopedics Corporation DBA Conventus Flower OrthopedK262344大型压缩螺钉TriMed, Inc.

官方来源

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