FDA 510(k)

SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF

K号: K153783 · 2016-05-04

决定日期2016-05-04

产品代码MAX

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

SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF is the device name listed in this FDA 510(k) record. The listed applicant is Spinevision S.A.. It received FDA 510(k) clearance on 2016-05-04 under 510(k) number K153783. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF?

SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF is a medical device that received FDA 510(k) clearance on 2016-05-04. The listed applicant is Spinevision S.A.. The 510(k) number is K153783.

When did SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF receive FDA 510(k) clearance?

SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF received FDA 510(k) clearance on 2016-05-04, under 510(k) number K153783.

Who is the listed applicant for SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF?

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

What is the FDA product code for SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF?

The FDA product code for SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF is MAX.

列明Spinevision S.A.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。

K160124LUMIS 套管螺钉固定系统，U.L.I.S. 螺钉固定系统

相关器械（代码：MAX）

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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