免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

IvyAIR 半月板系统，弯曲型，IvyAIR 半月板系统，直型，IvyAIR 半月板系统，反向弯曲型

K号: K153087 · 2016-07-14

申请人Ivy Sports Medicine, LLC
决定日期2016-07-14
产品代码GAT
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved is the device name listed in this FDA 510(k) record. The listed applicant is Ivy Sports Medicine, LLC. It received FDA 510(k) clearance on 2016-07-14 under 510(k) number K153087. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved?

IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved is a medical device that received FDA 510(k) clearance on 2016-07-14. The listed applicant is Ivy Sports Medicine, LLC. The 510(k) number is K153087.

When did IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved receive FDA 510(k) clearance?

IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved received FDA 510(k) clearance on 2016-07-14, under 510(k) number K153087.

Who is the listed applicant for IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved?

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

What is the FDA product code for IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved?

The FDA product code for IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved is GAT.

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Ivy Sports Medicine, 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。

K170364胶原半月板植入物XL

相关器械（代码：GAT）

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。

K253910Stitch - 缝线钢丝和胶带GM Dos Reis Industria e Comercio Ltda.K261021EasyWhip系列Winter Innovations, Inc.K260775聚乙烯；聚乙烯融合；聚乙烯OrthoTape™Teleflex Medical, LLCK254275HyperSuture全绿色延长线Threadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145预缝合肌腱Rti Surgical, Inc.

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。

↑