FDA 510(k)

Endoskeleton TCS Interbody Fusion Device

K号: K191565 · 2019-08-06

决定日期2019-08-06

产品代码OVE

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

Endoskeleton TCS Interbody Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Titan Spine, Inc.. It received FDA 510(k) clearance on 2019-08-06 under 510(k) number K191565. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Endoskeleton TCS Interbody Fusion Device?

Endoskeleton TCS Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2019-08-06. The listed applicant is Titan Spine, Inc.. The 510(k) number is K191565.

When did Endoskeleton TCS Interbody Fusion Device receive FDA 510(k) clearance?

Endoskeleton TCS Interbody Fusion Device received FDA 510(k) clearance on 2019-08-06, under 510(k) number K191565.

Who is the listed applicant for Endoskeleton TCS Interbody Fusion Device?

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

What is the FDA product code for Endoskeleton TCS Interbody Fusion Device?

The FDA product code for Endoskeleton TCS Interbody Fusion Device is OVE.

列明Titan Spine, Inc.为申报人的其他记录

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