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ODP

Intervertebral Fusion Device With Bone Graft, Cervical

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)
48 件
其中 Summary 已存档
43 份,可直接下载
FDA 历史累计 510(k)
354 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.

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)(48 件)

数据窗口为最近三年。最新一件:2026-08-26。

510(k) 号批准日期申请人器械名称摘要
K2625952026-08-26Wenzel Spine, Inc.VariLift-C Cervical Interbody Fusion SystemPDF
K2624892026-08-18L&K BIOMED Co., Ltd.BluEX Cervical Expandable Cage SystemFDA
K2530412026-07-23Fims Co., Ltd.3d Cage CervicalPDF
K2620612026-07-17Stryker SpineTritanium® C Anterior Cervical Cage; Tritanium® PL C…PDF
K2541302026-07-08C.A. Medical, LLCC.A. Medical Interbody Fusion SystemPDF
K2608402026-05-16L&K BIOMED Co., Ltd.BluEX Cervical Expandable Cage SystemFDA
K2608502026-05-12Osteomni, Inc.OSTEOMNI SPINAL CAGES SYSTEMPDF
K2605492026-04-24Zsfab, Inc.ZSFab Cervical Interbody System and ZSFab Lumbar Int…PDF
K2532602026-04-16SpineCraftORIO-3D Cage SystemPDF
K2603402026-04-13HC Biologics, LLCHC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OST…PDF
K2423032026-04-01Orthomod, LLCMOD-CPDF
K2522402026-03-30Spectrum SpineSpectrum Spine Cervical Cage System; Spectrum Spine …PDF
K2524322026-03-25Spinepoint, LLCFlex-Z™ Cervical CagePDF
K2541052026-02-13NanoHive Medical, LLCHive™ Standalone Cervical System and Hive™ C Interbo…PDF
K2522052026-01-16Curiteva, Inc.Curiteva Porous PEEK Cervical Interbody System; Curi…PDF
K2540612026-01-15Curiteva, Inc.Curiteva Porous PEEK Cervical Interbody Fusion Syste…PDF
K2522192026-01-14Sync SurgicalCervical Interbody and VBR Fusion SystemPDF
K2527112026-01-08Intelivation TechnologiesAdvantage-C™ Ti3D Cervical Interbody Fusion DevicePDF
K2528942026-01-06Carlsmed, Inc.aprevo® cervical interbody systemFDA
K2527812025-12-19Mikron Makina Sanayi VE Tic. Ltd. Sti.MSFX MIKRON PEEK CAGESPDF
K2507642025-12-05Lincotek MedicalSpineLinc Anterior Cervical Implant SystemPDF
K2507692025-11-24Precision Spine, Inc.Dakota LP SystemPDF
K2526862025-11-21Effortmed, LLCEffortMed PEEK Cages & Corpectomy CagesPDF
K2505602025-11-21NGMedical GmbHBEE HAPDF
K2527372025-10-10Degen MedicalDeGen Medical Latitude-C AM Cervical Interbody Fusio…PDF
K2503352025-08-29K&J ConsultingIVA & AEON Cervical and Lumbar Cage SystemPDF
K2510802025-07-03Alphatec Spine, Inc.IdentiTi II Cervical Interbody SystemFDA
K2506052025-03-12Cutting Edge Spine, LLCEVOL® ha – Hyper C Cervical Interbody Fusion SystemPDF
K2439152025-02-18Jeil Medical CorporationFIX-C 3D Ti ACIF SystemPDF
K2436732025-01-29Xenco Medical, LLCXenco Medical CancelleX Cervical Interbody SystemPDF
K2422602024-11-15Carlsmed, Inc.aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; apre…PDF
K2427342024-11-07ZsfabZSFab Cervical Interbody System; ZSFab Lumbar Interb…PDF
K2421952024-11-04ZheJiang Decans Medical Devices Co., L…Gemini Cervical Fusion Cage SystemPDF
K2417382024-08-20GS Medical Co., Ltd.PYXIS 3D Titanium Cervical Cage systemPDF
K2408932024-06-28Artfx MedicalARTFX MEDICAL Cervical PEEK CagesPDF
K2408382024-05-30Spectrum Spine, Inc.Spectrum Spine Cervical Cage SystemPDF
K2413962024-05-23Ulrich Medical USA, Inc.uCerv Flux™-C 3D Porous Titanium Cervical InterbodyPDF
K2326192024-03-19Sapphire Medical GroupMATRIX HA PEEK Cervical IBF SystemPDF
K2404162024-03-12Nexus Spine, LLCTranquil-C Interbody SystemPDF
K2313712024-01-12NGMedical GmbHBEE Cervical CagePDF
K2338392023-12-20Gbs Commonwealth Co., Ltd.Peridot-PT Anterior Cervical Intervertebral body fus…PDF
K2306392023-12-01Acuity Surgical Devices, LLCAlign Cervical Interbody Fusion SystemPDF
K2330842023-11-21Gbs Commonwealth Co., Ltd.Peridot-PT Anterior Cervical Intervertebral body fus…PDF
K2318362023-10-30Vy Spine, LLCClariVy™ Cervical IBF SystemPDF
K2304782023-10-19Acro Composites, LLCAcro Composites Interbody SystemPDF
K2318992023-10-17Innovasis, Inc.HAtetracell™-C Titanium Cervical IBF SystemFDA
K2328222023-10-13Gbs Commonwealth Co., Ltd.Peridot-TD Spacer system (The Peridot-TD Interverteb…PDF
K2310762023-09-27Wenzel Spine, Inc.VariLift®-C Interbody Fusion SystemPDF

其中 43 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: 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。