ODP
- 产品代码
- ODP
- 器械名称
- Intervertebral Fusion Device With Bone Graft, 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)
- 354 件
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.
该代码近三年的 510(k)（48 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K262595 | 2026-08-26 | Wenzel Spine, Inc. | VariLift-C Cervical Interbody Fusion System 摘要 |
| K262489 | 2026-08-18 | L&K BIOMED Co., Ltd. | BluEX Cervical Expandable Cage System 摘要 |
| K253041 | 2026-07-23 | Fims Co., Ltd. | 3d Cage Cervical 摘要 |
| K262061 | 2026-07-17 | Stryker Spine | Tritanium® C Anterior Cervical Cage; Tritanium® PL C 摘要 |
| K254130 | 2026-07-08 | C.A. Medical, LLC | C.A. Medical Interbody Fusion System 摘要 |
| K260840 | 2026-05-16 | L&K BIOMED Co., Ltd. | BluEX Cervical Expandable Cage System 摘要 |
| K260850 | 2026-05-12 | Osteomni, Inc. | OSTEOMNI SPINAL CAGES SYSTEM 摘要 |
| K260549 | 2026-04-24 | Zsfab, Inc. | ZSFab Cervical Interbody System and ZSFab Lumbar Int 摘要 |
| K253260 | 2026-04-16 | SpineCraft | ORIO-3D Cage System 摘要 |
| K260340 | 2026-04-13 | HC Biologics, LLC | HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OST 摘要 |
| K242303 | 2026-04-01 | Orthomod, LLC | MOD-C 摘要 |
| K252240 | 2026-03-30 | Spectrum Spine | Spectrum Spine Cervical Cage System; Spectrum Spine 摘要 |
| K252432 | 2026-03-25 | Spinepoint, LLC | Flex-Z Cervical Cage 摘要 |
| K254105 | 2026-02-13 | NanoHive Medical, LLC | Hive Standalone Cervical System and Hive C Interbo 摘要 |
| K252205 | 2026-01-16 | Curiteva, Inc. | Curiteva Porous PEEK Cervical Interbody System; Curi 摘要 |
| K254061 | 2026-01-15 | Curiteva, Inc. | Curiteva Porous PEEK Cervical Interbody Fusion Syste 摘要 |
| K252219 | 2026-01-14 | Sync Surgical | Cervical Interbody and VBR Fusion System 摘要 |
| K252711 | 2026-01-08 | Intelivation Technologies | Advantage-C Ti3D Cervical Interbody Fusion Device 摘要 |
| K252894 | 2026-01-06 | Carlsmed, Inc. | aprevo® cervical interbody system 摘要 |
| K252781 | 2025-12-19 | Mikron Makina Sanayi VE Tic. Ltd. Sti. | MSFX MIKRON PEEK CAGES 摘要 |
| K250764 | 2025-12-05 | Lincotek Medical | SpineLinc Anterior Cervical Implant System 摘要 |
| K250769 | 2025-11-24 | Precision Spine, Inc. | Dakota LP System 摘要 |
| K252686 | 2025-11-21 | Effortmed, LLC | EffortMed PEEK Cages & Corpectomy Cages 摘要 |
| K250560 | 2025-11-21 | NGMedical GmbH | BEE HA 摘要 |
| K252737 | 2025-10-10 | Degen Medical | DeGen Medical Latitude-C AM Cervical Interbody Fusio 摘要 |
| K250335 | 2025-08-29 | K&J Consulting | IVA & AEON Cervical and Lumbar Cage System 摘要 |
| K251080 | 2025-07-03 | Alphatec Spine, Inc. | IdentiTi II Cervical Interbody System 摘要 |
| K250605 | 2025-03-12 | Cutting Edge Spine, LLC | EVOL® ha Hyper C Cervical Interbody Fusion System 摘要 |
| K243915 | 2025-02-18 | Jeil Medical Corporation | FIX-C 3D Ti ACIF System 摘要 |
| K243673 | 2025-01-29 | Xenco Medical, LLC | Xenco Medical CancelleX Cervical Interbody System 摘要 |
| K242260 | 2024-11-15 | Carlsmed, Inc. | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; apre 摘要 |
| K242734 | 2024-11-07 | Zsfab | ZSFab Cervical Interbody System; ZSFab Lumbar Interb 摘要 |
| K242195 | 2024-11-04 | ZheJiang Decans Medical Devices Co., L | Gemini Cervical Fusion Cage System 摘要 |
| K241738 | 2024-08-20 | GS Medical Co., Ltd. | PYXIS 3D Titanium Cervical Cage system 摘要 |
| K240893 | 2024-06-28 | Artfx Medical | ARTFX MEDICAL Cervical PEEK Cages 摘要 |
| K240838 | 2024-05-30 | Spectrum Spine, Inc. | Spectrum Spine Cervical Cage System 摘要 |
| K241396 | 2024-05-23 | Ulrich Medical USA, Inc. | uCerv Flux-C 3D Porous Titanium Cervical Interbody 摘要 |
| K232619 | 2024-03-19 | Sapphire Medical Group | MATRIX HA PEEK Cervical IBF System 摘要 |
| K240416 | 2024-03-12 | Nexus Spine, LLC | Tranquil-C Interbody System 摘要 |
| K231371 | 2024-01-12 | NGMedical GmbH | BEE Cervical Cage 摘要 |
| K233839 | 2023-12-20 | Gbs Commonwealth Co., Ltd. | Peridot-PT Anterior Cervical Intervertebral body fus 摘要 |
| K230639 | 2023-12-01 | Acuity Surgical Devices, LLC | Align Cervical Interbody Fusion System 摘要 |
| K233084 | 2023-11-21 | Gbs Commonwealth Co., Ltd. | Peridot-PT Anterior Cervical Intervertebral body fus 摘要 |
| K231836 | 2023-10-30 | Vy Spine, LLC | ClariVy Cervical IBF System 摘要 |
| K230478 | 2023-10-19 | Acro Composites, LLC | Acro Composites Interbody System 摘要 |
| K231899 | 2023-10-17 | Innovasis, Inc. | HAtetracell-C Titanium Cervical IBF System 摘要 |
| K232822 | 2023-10-13 | Gbs Commonwealth Co., Ltd. | Peridot-TD Spacer system (The Peridot-TD Interverteb 摘要 |
| K231076 | 2023-09-27 | Wenzel Spine, Inc. | VariLift®-C Interbody Fusion System 摘要 |
FDA 官方分类页： ODP
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。