FDA 510(k)

共和国脊柱恢复颈椎椎间融合系统

K号: K190889 · 2019-06-19

决定日期2019-06-19

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

Republic Spine Restore Cervical Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Republic Spine, LLC. It received FDA 510(k) clearance on 2019-06-19 under 510(k) number K190889. 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 Republic Spine Restore Cervical Interbody Fusion System?

Republic Spine Restore Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2019-06-19. The listed applicant is Republic Spine, LLC. The 510(k) number is K190889.

When did Republic Spine Restore Cervical Interbody Fusion System receive FDA 510(k) clearance?

Republic Spine Restore Cervical Interbody Fusion System received FDA 510(k) clearance on 2019-06-19, under 510(k) number K190889.

Who is the listed applicant for Republic Spine Restore Cervical Interbody Fusion System?

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

What is the FDA product code for Republic Spine Restore Cervical Interbody Fusion System?

The FDA product code for Republic Spine Restore Cervical Interbody Fusion System is ODP.

列明Republic Spine, 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。

K223096Dark Star 变形椎弓根螺钉系统 K212028Dark Star 导航仪器系统 K201420共和国脊柱暗星脊柱系统 K190398共和国脊柱恢复椎体融合系统 K181495共和国脊柱暗星脊柱系统

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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