OVD
- 产品代码
- OVD
- 器械名称
- Intervertebral Fusion Device With Integrated Fixation, Lumbar
- 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)
- 204 件
FDA 分类定义
Intended to stabilize lumbar 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)（34 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K261408 | 2026-08-03 | Elevation Spine | SABER-XA System 摘要 |
| K261809 | 2026-07-31 | Foundation Surgical Group | Interwedge® Standalone Lateral 摘要 |
| K261353 | 2026-07-15 | Kyocera Medical Technologies, Inc. | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) Sys 摘要 |
| K260810 | 2026-06-10 | Tyber Medical, LLC | Anteralign LS coverplate 摘要 |
| K254202 | 2026-05-05 | Medacta International S.A. | MectaLIF 3D Metal Anterior 摘要 |
| K253401 | 2026-04-29 | Globus Medical, Inc. | SCRIPT Implant System 摘要 |
| K253559 | 2026-02-25 | Spinal Elements, Inc. | Ventana A Anterior Lumbar Interbody System 摘要 |
| K251829 | 2025-12-08 | Degen Medical | DeGen Medical Patient Specific Implant (PSI) System 摘要 |
| K251575 | 2025-09-03 | Alphatec Spine | IdentiTi II ALIF Standalone Interbody System; Trans 摘要 |
| K250072 | 2025-07-10 | Avalign Technologies, Inc. | CONDUIT SYNFIX Evolution Secured Spacer System 摘要 |
| K251644 | 2025-06-24 | Pro Surgical, Inc. | ProAM ALIF System 摘要 |
| K250845 | 2025-06-18 | Curiteva, Inc. | Curiteva Porous PEEK Standalone ALIF System 摘要 |
| K251459 | 2025-06-12 | Novapproach Spine, LLC | OneLIF Interbody Fusion System 摘要 |
| K243934 | 2025-04-30 | Nexus Spine, LLC | Stable-L Lumbar Interbody System 摘要 |
| K243386 | 2025-04-22 | Acuity Surgical Devices, LLC | Ventris Intervertebral Body Fusion Device 摘要 |
| K250603 | 2025-03-24 | Innovasis | AxTiHA® Stand-Alone ALIF System 摘要 |
| K243802 | 2025-03-17 | Carlsmed, Inc. | aprevo® anterior and lateral lumbar interbody fusion 摘要 |
| K243635 | 2024-12-13 | Carlsmed, Inc. | aprevo® anterior lumbar interbody fusion device with 摘要 |
| K243191 | 2024-11-26 | Atlas Spine, Inc. | Atlas Spine Lateral Expandable Interbody System |
| K241077 | 2024-10-29 | Degen Medical | DeGen Medical Patient Specific Implant (PSI) System 摘要 |
| K241992 | 2024-10-28 | Medtronic Sofamor Danek USA, Inc. | Catalyft LS Expandable Interbody System 摘要 |
| K241477 | 2024-10-09 | Carlsmed, Inc. | aprevo® anterior lumbar interbody fusion device with 摘要 |
| K241487 | 2024-10-02 | Foundation Surgical Group, Inc. | Interwedge® Standalone Lateral 摘要 |
| K241321 | 2024-07-18 | Spineart SA | Juliet® Ti LL Lumbar Interbody Device 摘要 |
| K240368 | 2024-05-15 | Evolution Spine | E3D-A Interbody System 摘要 |
| K240126 | 2024-05-03 | Pro Surgical, Inc. | ProAM ALIF System 摘要 |
| K240623 | 2024-04-24 | Omnia Medical, LLC | Omnia Medical TiBrid-SA System 摘要 |
| K233966 | 2024-04-22 | 4Web Medical, Inc. | Anterior Spine Truss System-Stand Alone (ASTS-SA) 摘要 |
| K232432 | 2024-01-30 | Evolution Spine | E3D-A Interbody System 摘要 |
| K232123 | 2023-10-18 | Medacta International S.A. | MectaLIF Anterior Lag Extension 摘要 |
| K231486 | 2023-10-12 | Nexus Spine, LLC | Stable-L Standalone Lumbar Interbody System 摘要 |
| K232097 | 2023-09-25 | Alphatec Spine, Inc. | IdentiTi ALIF Interbody Systems 摘要 |
| K232530 | 2023-09-18 | Nexus Spine, LLC | Stable-L Standalone Lumbar Interbody System, Stable- 摘要 |
| K232154 | 2023-09-11 | MiRus, LLC | MiRus 3DR Lateral Lumbar Interbody Fusion System wit 摘要 |
FDA 官方分类页： OVD
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。