FDA 510(k)

后路融合板/HA后路融合板（Minuteman G1），Minuteman G3/HA Minuteman G3，HA Minuteman G3-R，Minuteman G5

K号: K221023 · 2022-08-19

决定日期2022-08-19

产品代码PEK

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

Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5 is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Simplicity, LLC. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K221023. The device is classified under product code PEK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5?

Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5 is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Spinal Simplicity, LLC. The 510(k) number is K221023.

When did Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5 receive FDA 510(k) clearance?

Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5 received FDA 510(k) clearance on 2022-08-19, under 510(k) number K221023.

Who is the listed applicant for Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5?

The FDA 510(k) record lists Spinal Simplicity, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5?

The FDA product code for Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5 is PEK.

列明Spinal Simplicity, LLC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。

K253250Minuteman® G6 MIS融合板 K250001Patriot SI植入系统 K240592沃尔夫定律前颈椎板系统 K232259Patriot-SI后植入系统 K234051Minuteman G5 MIS融合板；Minuteman G1（后融合板/HA后融合板）；HA Minuteman G3-R MIS融合板；Minuteman G3/HA Minuteman G3 K231923Liberty SI侧向植入系统

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官方来源

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