FDA 510(k)

CD Horizon™ 穿孔螺钉套装，CD Horizon™ 脊柱系统，Kyphon™ HV-R™ 骨水泥

K号: K201362 · 2020-08-19

决定日期2020-08-19

产品代码PML

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

CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2020-08-19 under 510(k) number K201362. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement?

CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement is a medical device that received FDA 510(k) clearance on 2020-08-19. The listed applicant is Medtronic. The 510(k) number is K201362.

When did CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement receive FDA 510(k) clearance?

CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement received FDA 510(k) clearance on 2020-08-19, under 510(k) number K201362.

Who is the listed applicant for CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement?

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

What is the FDA product code for CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement?

The FDA product code for CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement is PML.

列明Medtronic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。

K253530Trexon™ 单丝合成可吸收缝合线 K251744Affinity Pixie™ 动脉过滤器带Balance™ 生物表面；Affinity® 儿科动脉血过滤器 K233433Sphere-9Dx 诊断导管 (AFR-00009)K240190MYOtherm XP 心肌停搏液输送系统（Cortiva 生物活性表面），MYOtherm XP 心肌停搏液输送系统（未涂层）K223494CD Horizon脊柱系统 K223178SelectSite C304 可弯曲导管系统，C315 递送系统

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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。