FDA 510(k)

OsteoCentric 集成髋关节固定器系统

K号: K230764 · 2023-04-18

决定日期2023-04-18

产品代码JDO

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

OsteoCentric Integrated Hip Fastener System is the device name listed in this FDA 510(k) record. The listed applicant is OsteoCentric Technologies. It received FDA 510(k) clearance on 2023-04-18 under 510(k) number K230764. The device is classified under product code JDO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OsteoCentric Integrated Hip Fastener System?

OsteoCentric Integrated Hip Fastener System is a medical device that received FDA 510(k) clearance on 2023-04-18. The listed applicant is OsteoCentric Technologies. The 510(k) number is K230764.

When did OsteoCentric Integrated Hip Fastener System receive FDA 510(k) clearance?

OsteoCentric Integrated Hip Fastener System received FDA 510(k) clearance on 2023-04-18, under 510(k) number K230764.

Who is the listed applicant for OsteoCentric Integrated Hip Fastener System?

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

What is the FDA product code for OsteoCentric Integrated Hip Fastener System?

The FDA product code for OsteoCentric Integrated Hip Fastener System is JDO.

列明OsteoCentric Technologies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。

K251913OsteoCentric® UnifiMI® TCS 接骨板系统 K250494OsteoCentric骨板和螺钉系统 K242691OsteoCentric Technologies 穿刺固定器和螺母 K230242OsteoCentric 牙科植入系统 K230226Integrity-SI® Fusion System K230595OsteoCentric ACL 固定系统

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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。