FDA 510(k)

Galileo 脊椎体置换装置

K号: K221542 · 2023-01-13

决定日期2023-01-13

产品代码PLR

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

Galileo Vertebral Body Replacement Device is the device name listed in this FDA 510(k) record. The listed applicant is Bright Spine. It received FDA 510(k) clearance on 2023-01-13 under 510(k) number K221542. The device is classified under product code PLR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Galileo Vertebral Body Replacement Device?

Galileo Vertebral Body Replacement Device is a medical device that received FDA 510(k) clearance on 2023-01-13. The listed applicant is Bright Spine. The 510(k) number is K221542.

When did Galileo Vertebral Body Replacement Device receive FDA 510(k) clearance?

Galileo Vertebral Body Replacement Device received FDA 510(k) clearance on 2023-01-13, under 510(k) number K221542.

Who is the listed applicant for Galileo Vertebral Body Replacement Device?

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

What is the FDA product code for Galileo Vertebral Body Replacement Device?

The FDA product code for Galileo Vertebral Body Replacement Device is PLR.

列明Bright Spine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。

K192145Galileo 脊椎体置换装置

官方来源

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