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FDA 510(k)

IdentiTi II ALIF 单独腰椎间融合系统；Transcend ALIF 单独腰椎间融合系统

K号: K251575 · 2025-09-03

申请人Alphatec Spine
决定日期2025-09-03
产品代码OVD
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

IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine. It received FDA 510(k) clearance on 2025-09-03 under 510(k) number K251575. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System?

IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System is a medical device that received FDA 510(k) clearance on 2025-09-03. The listed applicant is Alphatec Spine. The 510(k) number is K251575.

When did IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System receive FDA 510(k) clearance?

IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System received FDA 510(k) clearance on 2025-09-03, under 510(k) number K251575.

Who is the listed applicant for IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System?

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

What is the FDA product code for IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System?

The FDA product code for IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System is OVD.

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Alphatec Spine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。

K241375IdentiTi 多孔钛腰椎间融合系统；IdentiTi NanoTec 腰椎间融合系统；IdentiTi 颈椎多孔钛腰椎间融合系统；IdentiTi NanoTec 颈椎腰椎间融合系统；IdentiTi 颈椎单独腰椎间融合系统；IdentiTi NanoTec 颈椎单独腰椎间融合系统；IdentiTi ALIF 单独腰椎间融合系统；IdentiTi NanoTec ALIF 单独腰椎间融合系统；Transcend PEEK 腰椎间融合系统；Transcend NanoTec 腰椎间融合系统；Transcend 颈椎 PEEK 腰椎间融合系统；Transcend NanoTec 颈椎腰椎间融合系统K240951Invictus机器人导航仪器K222028IdentiTi 多孔钛腰椎间融合系统，IdentiTi NanoTec 腰椎间融合系统，Transcend PEEK 腰椎间融合系统，Transcend NanoTec 腰椎间融合系统，IdentiTi ALIF 单独腰椎间融合系统，IdentiTi NanoTec ALIF 单独腰椎间融合系统K191185Solanas®后部OCT固定系统K160958Battalion 通用隔气系统

相关器械（代码：OVD）

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。

K262025Innovasis AxTiHA® 独立式 ALIF 系统；Innovasis TxTiHA® IBF 系统；Innovasis HAtetracell®-C 钛合金颈椎 IBF 系统INNO Holdings Inc. DBA InnovasisK261408SABER-XA系统Elevation SpineK261809Interwedge® 独立侧站Foundation Surgical GroupK261353Tesera-K 前路腰椎椎间融合（ALIF）系统；Tesera-K XL 系统；腰椎锚定系统Kyocera Medical Technologies, Inc.K260810Anteralign LS盖板Tyber Medical, LLCK254202MectaLIF 3D金属前部Medacta International S.A.

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。

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