FDA 510(k)

Biomet微型固定SternaLock 360胸骨闭合系统

K号: K163007 · 2016-11-23

决定日期2016-11-23

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

Biomet Microfixation SternaLock 360 Sternal Closure System is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Microfixation. It received FDA 510(k) clearance on 2016-11-23 under 510(k) number K163007. 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 Biomet Microfixation SternaLock 360 Sternal Closure System?

Biomet Microfixation SternaLock 360 Sternal Closure System is a medical device that received FDA 510(k) clearance on 2016-11-23. The listed applicant is Biomet Microfixation. The 510(k) number is K163007.

When did Biomet Microfixation SternaLock 360 Sternal Closure System receive FDA 510(k) clearance?

Biomet Microfixation SternaLock 360 Sternal Closure System received FDA 510(k) clearance on 2016-11-23, under 510(k) number K163007.

Who is the listed applicant for Biomet Microfixation SternaLock 360 Sternal Closure System?

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

What is the FDA product code for Biomet Microfixation SternaLock 360 Sternal Closure System?

The FDA product code for Biomet Microfixation SternaLock 360 Sternal Closure System is HRS.

列明Biomet Microfixation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。

K261002Pectus Blu 系统 K241709Pectus Blu支撑杆系统 K2231992.1 x 255mm Drill, 22mm Stop K212782SternaLock 胸骨闭合系统 K212608RibFix Blu 胸部固定系统 K213712Pectus Support Bar 系统

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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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