FDA 510(k)

DePuy Synthes 2.7mm VA LCP 锁骨板系统，DePuy Synthes 2.7mm VA LCP 锁骨钩板系统

K号: K203414 · 2020-12-16

决定日期2020-12-16

产品代码HRS

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

DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Synthes. It received FDA 510(k) clearance on 2020-12-16 under 510(k) number K203414. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System?

DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System is a medical device that received FDA 510(k) clearance on 2020-12-16. The listed applicant is DePuy Synthes. The 510(k) number is K203414.

When did DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System receive FDA 510(k) clearance?

DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System received FDA 510(k) clearance on 2020-12-16, under 510(k) number K203414.

Who is the listed applicant for DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System?

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 DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System?

The FDA product code for DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System is HRS.

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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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。