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FDA 510(k)

Synthes 4.5mm VA-LCP弯曲髁突板系统线扩展，可变角度定位销

K号: K162124 · 2017-03-29

申请人DePuy Synthes
决定日期2017-03-29
产品代码JDP
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

Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Synthes. It received FDA 510(k) clearance on 2017-03-29 under 510(k) number K162124. The device is classified under product code JDP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins?

Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins is a medical device that received FDA 510(k) clearance on 2017-03-29. The listed applicant is DePuy Synthes. The 510(k) number is K162124.

When did Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins receive FDA 510(k) clearance?

Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins received FDA 510(k) clearance on 2017-03-29, under 510(k) number K162124.

Who is the listed applicant for Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins?

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

What is the FDA product code for Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins?

The FDA product code for Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins is JDP.

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DePuy Synthes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。

K233696DePuy Synthes 逆行股骨钉高级系统K233256机器人集成工具K233255CROSSNAV 导航启用工具K233254TELIGEN 系统导航就绪仪器K233665DePuy Synthes VOLT® 小碎片钢板系统，DePuy Synthes VOLT® 小碎片钢板系统K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT 系统

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官方来源

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