FDA 510(k)

Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology

K号: K192718 · 2019-12-20

申请人Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.

决定日期2019-12-20

产品代码MAX

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

Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K192718. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology?

Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.. The 510(k) number is K192718.

When did Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology receive FDA 510(k) clearance?

Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology received FDA 510(k) clearance on 2019-12-20, under 510(k) number K192718.

Who is the listed applicant for Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology?

The FDA 510(k) record lists Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology?

The FDA product code for Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology is MAX.

列明Pioneer Surgical Technology, Inc., Dba Rti Surgical, 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。

K201497EVOS 连接系统 K200095Streamline导航工具 K193468三氚胸骨电缆板系统 K192800Streamline TL脊柱固定系统 K190498Fortilink® IBF System with TETRAfuse®3D Technology，包括以下设计：Fortilink®-TS IBF System，Fortilink®-L I BF System，Fortilink®-C IBF System K183060CervAlign™ 前颈椎板系统

查看所有 13 个设备 →

相关器械（代码：MAX）

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。

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