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FDA 510(k)

OsteoSinter® EVANS 和 COTTON 垫块及相关配件

K号: K240461 · 2024-12-06

申请人Ames Medical Prosthetic Solutions, S.A.U.
决定日期2024-12-06
产品代码PLF
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

OsteoSinter® EVANS and COTTON wedges and related accessories is the device name listed in this FDA 510(k) record. The listed applicant is Ames Medical Prosthetic Solutions, S.A.U.. It received FDA 510(k) clearance on 2024-12-06 under 510(k) number K240461. The device is classified under product code PLF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OsteoSinter® EVANS and COTTON wedges and related accessories?

OsteoSinter® EVANS and COTTON wedges and related accessories is a medical device that received FDA 510(k) clearance on 2024-12-06. The listed applicant is Ames Medical Prosthetic Solutions, S.A.U.. The 510(k) number is K240461.

When did OsteoSinter® EVANS and COTTON wedges and related accessories receive FDA 510(k) clearance?

OsteoSinter® EVANS and COTTON wedges and related accessories received FDA 510(k) clearance on 2024-12-06, under 510(k) number K240461.

Who is the listed applicant for OsteoSinter® EVANS and COTTON wedges and related accessories?

The FDA 510(k) record lists Ames Medical Prosthetic Solutions, S.A.U. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OsteoSinter® EVANS and COTTON wedges and related accessories?

The FDA product code for OsteoSinter® EVANS and COTTON wedges and related accessories is PLF.

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

相关器械（代码：PLF）

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。

K252733ATLAS® 可扩张骨切开楔形系统MiRus, LLCK252254骨切开楔形系统Sinaptic SurgicalK251791Auxano® 凸块固定系统Auxano Medical, LLCK243231三角 PEEK HA 楔形物Nvision Biomedical TechnologiesK234116三角三角 HA 独立楔形固定系统Nvision Biomedical TechnologiesK231496TITAN 3-D 套楔系统Paragon 28, Inc.

官方来源

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