FDA 510(k)

ENZA 零轮廓前路椎体融合术

K号: K153720 · 2016-05-03

决定日期2016-05-03

产品代码OVD

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

ENZA Zero-Profile Anterior Interbody Fusion is the device name listed in this FDA 510(k) record. The listed applicant is Camber Spine Technologies. It received FDA 510(k) clearance on 2016-05-03 under 510(k) number K153720. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ENZA Zero-Profile Anterior Interbody Fusion?

ENZA Zero-Profile Anterior Interbody Fusion is a medical device that received FDA 510(k) clearance on 2016-05-03. The listed applicant is Camber Spine Technologies. The 510(k) number is K153720.

When did ENZA Zero-Profile Anterior Interbody Fusion receive FDA 510(k) clearance?

ENZA Zero-Profile Anterior Interbody Fusion received FDA 510(k) clearance on 2016-05-03, under 510(k) number K153720.

Who is the listed applicant for ENZA Zero-Profile Anterior Interbody Fusion?

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

What is the FDA product code for ENZA Zero-Profile Anterior Interbody Fusion?

The FDA product code for ENZA Zero-Profile Anterior Interbody Fusion is OVD.

列明Camber Spine Technologies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。

K234077SPIRA® 腰椎前间隙器 K233972Camber 骶髂（SI）固定系统 K230942SPIRA® 腰椎后间隙器 K221324ENZA-O 钛合金侧前方腰椎椎体间融合术（ALIF）K223837SPIRA®-C 集成固定系统 K220038Camber 脊柱导航系统

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官方来源

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