INTEGRATE -C 腰椎融合系统
K号: K222004 · 2023-04-28
广告
申请人Happe Spine
决定日期2023-04-28
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
INTEGRATE -C Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Happe Spine. It received FDA 510(k) clearance on 2023-04-28 under 510(k) number K222004. 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 INTEGRATE -C Interbody Fusion System?
INTEGRATE -C Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2023-04-28. The listed applicant is Happe Spine. The 510(k) number is K222004.
When did INTEGRATE -C Interbody Fusion System receive FDA 510(k) clearance?
INTEGRATE -C Interbody Fusion System received FDA 510(k) clearance on 2023-04-28, under 510(k) number K222004.
Who is the listed applicant for INTEGRATE -C Interbody Fusion System?
The FDA 510(k) record lists Happe Spine as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for INTEGRATE -C Interbody Fusion System?
The FDA product code for INTEGRATE -C Interbody Fusion System is ODP.
相关临床试验
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。
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 SpineK254130C.A. 医疗椎间融合系统C.A. Medical, LLCK260840BluEX宫颈可扩张笼系统L&K BIOMED Co., Ltd.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
广告