FDA 510(k)

GEO 四肢和踝关节钢板系统

K号: K212334 · 2021-09-21

决定日期2021-09-21

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

GEO Extremity and Ankle Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Gramercy Extremity Orthopedics, LLC. It received FDA 510(k) clearance on 2021-09-21 under 510(k) number K212334. 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 GEO Extremity and Ankle Plating System?

GEO Extremity and Ankle Plating System is a medical device that received FDA 510(k) clearance on 2021-09-21. The listed applicant is Gramercy Extremity Orthopedics, LLC. The 510(k) number is K212334.

When did GEO Extremity and Ankle Plating System receive FDA 510(k) clearance?

GEO Extremity and Ankle Plating System received FDA 510(k) clearance on 2021-09-21, under 510(k) number K212334.

Who is the listed applicant for GEO Extremity and Ankle Plating System?

The FDA 510(k) record lists Gramercy Extremity Orthopedics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GEO Extremity and Ankle Plating System?

The FDA product code for GEO Extremity and Ankle Plating System is HRS.

列明Gramercy Extremity Orthopedics, 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。

K210534GEO FirstFUSE 1st MTP 关节融合钢板系统 K202817GEO 骨螺钉系统 K200108GEO 1st MTP 关节融合钢板系统 K182212Geo 纽扣系统

相关器械（代码：HRS）

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。

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官方来源

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