FDA 510(k)

Peridot-EX 可扩张椎间融合系统

K号: K232292 · 2023-11-07

决定日期2023-11-07

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

Peridot-EX Expandable Intervertebral Body Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Gbs Commonwealth Co., Ltd.. It received FDA 510(k) clearance on 2023-11-07 under 510(k) number K232292. 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 Peridot-EX Expandable Intervertebral Body Fusion System?

Peridot-EX Expandable Intervertebral Body Fusion System is a medical device that received FDA 510(k) clearance on 2023-11-07. The listed applicant is Gbs Commonwealth Co., Ltd.. The 510(k) number is K232292.

When did Peridot-EX Expandable Intervertebral Body Fusion System receive FDA 510(k) clearance?

Peridot-EX Expandable Intervertebral Body Fusion System received FDA 510(k) clearance on 2023-11-07, under 510(k) number K232292.

Who is the listed applicant for Peridot-EX Expandable Intervertebral Body Fusion System?

The FDA 510(k) record lists Gbs Commonwealth Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Peridot-EX Expandable Intervertebral Body Fusion System?

The FDA product code for Peridot-EX Expandable Intervertebral Body Fusion System is MAX.

列明Gbs Commonwealth Co., Ltd.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。

K233839Peridot-PT 颈前椎间融合系统；Peridot-PT 椎间融合系统；Peridot-TD 颈前椎间融合系统；Peridot-TD 椎间融合系统 K233084Peridot-PT 颈前椎间融合系统，Peridot-PT 椎间融合系统 K232822Peridot-TD 隔板系统（Peridot-TD 椎间融合系统），颈前椎间融合 - ACIF（Peridot-TD 颈前椎间融合系统）K230708Peridot-TD 隔板系统（Peridot-TD 椎间融合系统）；颈前椎间融合-ACIF（Peridot-TD 颈前椎间融合系统）K213755Peridot-PT 颈前椎间融合系统，Peridot-PT 椎间融合系统 K213980Peridot 脊柱椎间融合系统

查看所有 14 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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