FDA 510(k)

PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro

K号: K210607 · 2021-07-09

决定日期2021-07-09

产品代码LOD

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

PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Medical GmbH. It received FDA 510(k) clearance on 2021-07-09 under 510(k) number K210607. The device is classified under product code LOD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro?

PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro is a medical device that received FDA 510(k) clearance on 2021-07-09. The listed applicant is Heraeus Medical GmbH. The 510(k) number is K210607.

When did PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro receive FDA 510(k) clearance?

PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro received FDA 510(k) clearance on 2021-07-09, under 510(k) number K210607.

Who is the listed applicant for PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro?

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

What is the FDA product code for PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro?

The FDA product code for PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro is LOD.

列明Heraeus Medical GmbH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。

K241674OSTEOPAL® V K234028COPAL®交换型G髋关节间隙器; COPAL® G+V K222570COPAL膝关节模具 K220492COPAL exchange G 髋关节间隙 K213812PALACOS MV pro K202475PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G

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