OVE

Intervertebral Fusion Device With Integrated Fixation, Cervical

产品代码
OVE
器械名称
Intervertebral Fusion Device With Integrated Fixation, Cervical
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 888.3080
FDA 专业组
Orthopedic
上市路径
需提交 510(k) 上市前通告
标记
属植入器械
该代码近三年的 510(k)
33 件
其中 Summary 已存档
28 份,可直接下载
FDA 历史累计 510(k)
166 件(全部年份;本站只收录近三年的明细)

FDA 分类定义

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

定义原文来自 FDA 器械分类库,属美国联邦政府作品(公有领域)。

该代码近三年的 510(k)(33 件)

数据窗口为最近三年。最新一件:2026-08-21。

510(k) 号批准日期申请人器械名称摘要
K2618822026-08-21Osseus Fusions Systems, LLCPisces-SC Standalone Cervical Interbody SystemFDA
K2614512026-07-31ZSFab, Inc.ZSAlign Cervical Interbody SystemPDF
K2620942026-07-22Evolution SpineE3D™-C Interbody SystemPDF
K2612792026-06-22Nexus SpineDeltaNEC Interbody SystemPDF
K2529822026-06-18Avalign Technologies, Inc.CONDUIT™ ZERO-P™ VA Secured Spacer SystemFDA
K2600362026-06-15Medyssey Co, Ltd.NeckTune™ 3D SA Cervical CagePDF
K2606602026-04-27Elevation SpineSABER-C SystemPDF
K2532132026-04-20ZheJiang Decans Medical Devices Co., LSAGI Cervical Cage SystemPDF
K2527742026-04-15ZheJiang Decans Medical Devices Co., LUni-C Cervical Cage SystemPDF
K2600382026-02-04Evolution SpineE3D™-C Interbody SystemPDF
K2538762025-12-22Globus Medical, Inc.HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)PDF
K2532002025-12-114Web Medical, Inc.Cervical Spine Truss System - Stand Alone (CSTS-SA)FDA
K2500762025-09-25InnovasisEndeavor™ Stand-Alone Cervical IBF SystemPDF
K2505402025-08-08Elevation SpineSABER-C SystemPDF
K2517352025-07-30Acuity Surgical Devices, LLCStabilis SA Cervical Stand-Alone System (Various PNsPDF
K2514312025-06-27Jeil Medical CorporationFIX-C PEEK ACIF SA SystemPDF
K2511172025-04-254Web MedicalCervical Spine Truss System (CSTS)FDA
K2429282025-04-10Kyocera Medical Technologies, Inc.Tesera-k SC SystemPDF
K2431882025-02-11Signus Medizintechnik GmbHCYLOX® STPDF
K2424832025-02-07Genesys SpineGenesys Spine AIS-C II Cervical Interbody Fusion SysPDF
K2425172024-11-20Pro Surgical, Inc.ProAM ACDF SystemPDF
K2418462024-08-12Evolution SpineE3D™-C Interbody SystemPDF
K2414672024-07-17Nexus Spine, LLCStable-C Interbody SystemPDF
K2406992024-05-10Spineart SASCARLET® AC-TiPDF
K2341192024-04-19Innosys Co., Ltd.UniSpace® Stand-Alone C CagePDF
K2407152024-03-22ClarianceIdys® C ZP 3DTiPDF
K2335942023-12-13Genesys SpineGenesys Spine 3DP AIS-C II Cervical Interbody SystemPDF
K2334142023-11-28SeaSpine Orthopedics CorporationShoreline ACS Interbody System; Shoreline RT InterboPDF
K2331912023-11-21Spinal Analytics & Geometrical ImplantTotalTi ACDF by SAGICOFDA
K2323482023-10-27MiRus, LLCRIGEL™ 3DR Standalone Anterior Cervical Interbody FuPDF
K2317042023-10-19Life Spine, Inc.Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystePDF
K2317392023-09-254Web Medical, Inc.Cervical Spine Truss System (CSTS)PDF
K2238692023-09-14Choice Spine, LLCChoiceSpine Blackhawk Ti Cervical Spacer SystemPDF

其中 28 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

FDA 官方分类页: OVE
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。