FDA 510(k)

FIREFLY® 椎弓根螺钉导航引导器

K号: K162419 · 2016-10-28

决定日期2016-10-28

产品代码PQC

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

FIREFLY® Pedicle Screw Navigation Guide is the device name listed in this FDA 510(k) record. The listed applicant is Mighty Oak Medical, Inc.. It received FDA 510(k) clearance on 2016-10-28 under 510(k) number K162419. The device is classified under product code PQC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FIREFLY® Pedicle Screw Navigation Guide?

FIREFLY® Pedicle Screw Navigation Guide is a medical device that received FDA 510(k) clearance on 2016-10-28. The listed applicant is Mighty Oak Medical, Inc.. The 510(k) number is K162419.

When did FIREFLY® Pedicle Screw Navigation Guide receive FDA 510(k) clearance?

FIREFLY® Pedicle Screw Navigation Guide received FDA 510(k) clearance on 2016-10-28, under 510(k) number K162419.

Who is the listed applicant for FIREFLY® Pedicle Screw Navigation Guide?

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

What is the FDA product code for FIREFLY® Pedicle Screw Navigation Guide?

The FDA product code for FIREFLY® Pedicle Screw Navigation Guide is PQC.

列明Mighty Oak Medical, 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。

K220132FIREFLY® 颈椎导航引导器 K181883FIREFLY® 中线导航引导器 K181399FIREFLY® 椎弓根螺钉导航引导器

相关器械（代码：PQC）

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。

K253472FIREFLY® 椎弓根螺钉导航引导器Mighty Oak Medical K231483MySpine 单侧导引器Medacta International S.A.K203673MySpine 椎弓根螺钉置入导引器扩展（MySpine 低轮廓导引器，MySpine MC和钻孔引导器，以及MySpine S2-翼/翼髂骨导引器）Medacta International S.A.K200792MySpine S2-翼/翼髂骨椎弓根螺钉置入导引器Medacta Inernational SA K181883FIREFLY® 中线导航引导器Mighty Oak Medical, Inc.K181399FIREFLY® 椎弓根螺钉导航引导器Mighty Oak Medical, Inc.

官方来源

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