FDA 510(k)

Spine Wave Gen II 可扩张椎间融合系统

K号: K152620 · 2016-01-15

决定日期2016-01-15

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

Spine Wave Gen II Expandable Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Spine Wave, Inc.. It received FDA 510(k) clearance on 2016-01-15 under 510(k) number K152620. 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 Spine Wave Gen II Expandable Interbody System?

Spine Wave Gen II Expandable Interbody System is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is Spine Wave, Inc.. The 510(k) number is K152620.

When did Spine Wave Gen II Expandable Interbody System receive FDA 510(k) clearance?

Spine Wave Gen II Expandable Interbody System received FDA 510(k) clearance on 2016-01-15, under 510(k) number K152620.

Who is the listed applicant for Spine Wave Gen II Expandable Interbody System?

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

What is the FDA product code for Spine Wave Gen II Expandable Interbody System?

The FDA product code for Spine Wave Gen II Expandable Interbody System is MAX.

列明Spine Wave, Inc.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。

K260286Dynamo® 脊柱水泥；Salvo® 脊柱系统 K261159Exceed® 双平面可扩张椎间系统 K243816Testa TP 旋转间隔系统 K251131Annex® 2 相邻级别系统 K243514Salvo®机器人导航仪器 K240685Salvo®脊柱系统

查看所有 24 个设备 →

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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