FDA 510(k)

CarboClear® X 椎弓根螺钉系统；CarboClear® X 导航仪器；CarboClear® X 高V+® 骨水泥开窗椎弓根螺钉系统

K号: K231280 · 2023-07-03

决定日期2023-07-03

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

CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement is the device name listed in this FDA 510(k) record. The listed applicant is CarboFix Orthopedics , Ltd.. It received FDA 510(k) clearance on 2023-07-03 under 510(k) number K231280. 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 CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement?

CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement is a medical device that received FDA 510(k) clearance on 2023-07-03. The listed applicant is CarboFix Orthopedics , Ltd.. The 510(k) number is K231280.

When did CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement receive FDA 510(k) clearance?

CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement received FDA 510(k) clearance on 2023-07-03, under 510(k) number K231280.

Who is the listed applicant for CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement?

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

What is the FDA product code for CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement?

The FDA product code for CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement is NKB.

列明CarboFix Orthopedics , Ltd.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。

K254045CarboClear® 后颈椎螺钉系统；CarboClear® 混合后颈椎螺钉系统 K243106CarboClear® 混合椎弓根螺钉系统 K233793CarboClear® X 椎弓根螺钉系统 K240846CarboClear® 混合椎弓根螺钉系统；CarboClear® 混合导航工具；CarboClear® 混合开窗椎弓根螺钉系统和高V+® 骨水泥；CarboClear® X 开窗椎弓根螺钉系统和高V+® 骨水泥 K233989CarboClear® 后颈椎螺钉系统 K233944CarboClear® X 椎弓根螺钉系统；CarboClear® X 导航仪器

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官方来源

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