FDA 510(k)

Hive™ 独立颈椎系统和 Hive™ C 椎间系统

K号: K254105 · 2026-02-13

决定日期2026-02-13

产品代码ODP

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

Hive™ Standalone Cervical System and Hive™ C Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is NanoHive Medical, LLC. It received FDA 510(k) clearance on 2026-02-13 under 510(k) number K254105. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Hive™ Standalone Cervical System and Hive™ C Interbody System?

Hive™ Standalone Cervical System and Hive™ C Interbody System is a medical device that received FDA 510(k) clearance on 2026-02-13. The listed applicant is NanoHive Medical, LLC. The 510(k) number is K254105.

When did Hive™ Standalone Cervical System and Hive™ C Interbody System receive FDA 510(k) clearance?

Hive™ Standalone Cervical System and Hive™ C Interbody System received FDA 510(k) clearance on 2026-02-13, under 510(k) number K254105.

Who is the listed applicant for Hive™ Standalone Cervical System and Hive™ C Interbody System?

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

What is the FDA product code for Hive™ Standalone Cervical System and Hive™ C Interbody System?

The FDA product code for Hive™ Standalone Cervical System and Hive™ C Interbody System is ODP.

列明NanoHive Medical, 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。

K231241NanoHive医疗腰椎椎间系统 K223190Hive™ 独立颈椎系统

相关器械（代码：ODP）

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。

K262595VariLift-C 颈椎椎间融合系统Wenzel Spine, Inc.K262489BluEX宫颈可扩张笼系统L&K BIOMED Co., Ltd.K2530413D颈椎笼Fims Co., Ltd.K262061Tritanium® C 前颈椎笼；Tritanium® PL笼；Tritanium® TL弯曲腰椎笼；Aero® -C 颈椎笼系统；AVS® Anchor-C 颈椎笼系统；AVS® TL PEEK间隔器；AVS® PL PEEK间隔器；AVS® 导航PEEK间隔器；AVS® AS PEEK间隔器；Monterey™ AL椎间系统；Aleutian IBF系统；Cascadia椎间系统；Chesapeake稳定系统；Sahara稳定系统；SANTORINI™ 脱位椎体笼系统；MOJAVE椎间系统；VLIFT VERTEBRAL BODY REPLACEMStryker Spine K254130C.A. 医疗椎间融合系统C.A. Medical, LLC K260840BluEX宫颈可扩张笼系统L&K BIOMED Co., Ltd.

官方来源

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