OVE
- 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.
该代码近三年的 510(k)(33 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K261882 | 2026-08-21 | Osseus Fusions Systems, LLC | Pisces-SC Standalone Cervical Interbody System | FDA |
| K261451 | 2026-07-31 | ZSFab, Inc. | ZSAlign Cervical Interbody System | |
| K262094 | 2026-07-22 | Evolution Spine | E3D-C Interbody System | |
| K261279 | 2026-06-22 | Nexus Spine | DeltaNEC Interbody System | |
| K252982 | 2026-06-18 | Avalign Technologies, Inc. | CONDUIT ZERO-P VA Secured Spacer System | FDA |
| K260036 | 2026-06-15 | Medyssey Co, Ltd. | NeckTune 3D SA Cervical Cage | |
| K260660 | 2026-04-27 | Elevation Spine | SABER-C System | |
| K253213 | 2026-04-20 | ZheJiang Decans Medical Devices Co., L | SAGI Cervical Cage System | |
| K252774 | 2026-04-15 | ZheJiang Decans Medical Devices Co., L | Uni-C Cervical Cage System | |
| K260038 | 2026-02-04 | Evolution Spine | E3D-C Interbody System | |
| K253876 | 2025-12-22 | Globus Medical, Inc. | HEDRON Cervical Spacers (HEDRON C-MIS Spacer) | |
| K253200 | 2025-12-11 | 4Web Medical, Inc. | Cervical Spine Truss System - Stand Alone (CSTS-SA) | FDA |
| K250076 | 2025-09-25 | Innovasis | Endeavor Stand-Alone Cervical IBF System | |
| K250540 | 2025-08-08 | Elevation Spine | SABER-C System | |
| K251735 | 2025-07-30 | Acuity Surgical Devices, LLC | Stabilis SA Cervical Stand-Alone System (Various PNs | |
| K251431 | 2025-06-27 | Jeil Medical Corporation | FIX-C PEEK ACIF SA System | |
| K251117 | 2025-04-25 | 4Web Medical | Cervical Spine Truss System (CSTS) | FDA |
| K242928 | 2025-04-10 | Kyocera Medical Technologies, Inc. | Tesera-k SC System | |
| K243188 | 2025-02-11 | Signus Medizintechnik GmbH | CYLOX® ST | |
| K242483 | 2025-02-07 | Genesys Spine | Genesys Spine AIS-C II Cervical Interbody Fusion Sys | |
| K242517 | 2024-11-20 | Pro Surgical, Inc. | ProAM ACDF System | |
| K241846 | 2024-08-12 | Evolution Spine | E3D-C Interbody System | |
| K241467 | 2024-07-17 | Nexus Spine, LLC | Stable-C Interbody System | |
| K240699 | 2024-05-10 | Spineart SA | SCARLET® AC-Ti | |
| K234119 | 2024-04-19 | Innosys Co., Ltd. | UniSpace® Stand-Alone C Cage | |
| K240715 | 2024-03-22 | Clariance | Idys® C ZP 3DTi | |
| K233594 | 2023-12-13 | Genesys Spine | Genesys Spine 3DP AIS-C II Cervical Interbody System | |
| K233414 | 2023-11-28 | SeaSpine Orthopedics Corporation | Shoreline ACS Interbody System; Shoreline RT Interbo | |
| K233191 | 2023-11-21 | Spinal Analytics & Geometrical Implant | TotalTi ACDF by SAGICO | FDA |
| K232348 | 2023-10-27 | MiRus, LLC | RIGEL 3DR Standalone Anterior Cervical Interbody Fu | |
| K231704 | 2023-10-19 | Life Spine, Inc. | Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer Syste | |
| K231739 | 2023-09-25 | 4Web Medical, Inc. | Cervical Spine Truss System (CSTS) | |
| K223869 | 2023-09-14 | Choice Spine, LLC | ChoiceSpine Blackhawk Ti Cervical Spacer System |
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。