CD HORIZON® Spinal System
K号: K162494 · 2016-10-04
广告
器械摘要
CD HORIZON® Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2016-10-04 under 510(k) number K162494. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the CD HORIZON® Spinal System?
CD HORIZON® Spinal System is a medical device that received FDA 510(k) clearance on 2016-10-04. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K162494.
When did CD HORIZON® Spinal System receive FDA 510(k) clearance?
CD HORIZON® Spinal System received FDA 510(k) clearance on 2016-10-04, under 510(k) number K162494.
Who is the listed applicant for CD HORIZON® Spinal System?
The FDA 510(k) record lists Medtronic Sofamor Danek USA, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CD HORIZON® Spinal System?
The FDA product code for CD HORIZON® Spinal System is NKB.
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。
NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING
列明Medtronic Sofamor Danek USA, 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。
K253011Catalyft PL Expandable Interbody SystemK261020Symmetrix™ L Spinal SystemK253656OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation SystemK260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemK254165Infinity™ OCT SystemK253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)
相关器械（代码：NKB）
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。
K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim SirketiK262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix MedicalK262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ 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