FDA 510(k)

GPC 品牌后路，非颈椎椎弓根螺钉脊柱系统

K号: K163096 · 2017-03-31

决定日期2017-03-31

产品代码NKB

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

GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Gpc Medical Limited. It received FDA 510(k) clearance on 2017-03-31 under 510(k) number K163096. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System?

GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is a medical device that received FDA 510(k) clearance on 2017-03-31. The listed applicant is Gpc Medical Limited. The 510(k) number is K163096.

When did GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System receive FDA 510(k) clearance?

GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System received FDA 510(k) clearance on 2017-03-31, under 510(k) number K163096.

Who is the listed applicant for GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System?

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

What is the FDA product code for GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System?

The FDA product code for GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is NKB.

列明Gpc Medical Limited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。

K203811GPC 内踝髓内钉系统 K210198GPC 2.4mm 可变角度锁定双柱掌骨远端桡骨板，6个头孔，GPC 2.4mm 可变角度锁定双柱掌骨远端桡骨板，7个头孔，2.4mm 可变角度锁定双柱掌骨远端桡骨板-窄，6个头孔，可变角度锁定螺钉 2.4mm，Stardrive

相关器械（代码：NKB）

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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