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OVD

Intervertebral Fusion Device With Integrated Fixation, Lumbar

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)
34 件
其中 Summary 已存档
29 份,可直接下载
FDA 历史累计 510(k)
204 件(全部年份;本站只收录近三年的明细)

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.

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)(34 件)

数据窗口为最近三年。最新一件:2026-08-03。

510(k) 号批准日期申请人器械名称摘要
K2614082026-08-03Elevation SpineSABER-XA SystemPDF
K2618092026-07-31Foundation Surgical GroupInterwedge® Standalone LateralPDF
K2613532026-07-15Kyocera Medical Technologies, Inc.Tesera-K Anterior Lumbar Interbody Fusion (ALIF) Sys…PDF
K2608102026-06-10Tyber Medical, LLCAnteralign LS coverplatePDF
K2542022026-05-05Medacta International S.A.MectaLIF 3D Metal AnteriorFDA
K2534012026-04-29Globus Medical, Inc.SCRIPT™ Implant SystemPDF
K2535592026-02-25Spinal Elements, Inc.Ventana™ A Anterior Lumbar Interbody SystemPDF
K2518292025-12-08Degen MedicalDeGen Medical Patient Specific Implant (PSI) SystemFDA
K2515752025-09-03Alphatec SpineIdentiTi™ II ALIF Standalone Interbody System; Trans…PDF
K2500722025-07-10Avalign Technologies, Inc.CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemPDF
K2516442025-06-24Pro Surgical, Inc.ProAM ALIF SystemPDF
K2508452025-06-18Curiteva, Inc.Curiteva Porous PEEK Standalone ALIF SystemPDF
K2514592025-06-12Novapproach Spine, LLCOneLIF™ Interbody Fusion SystemPDF
K2439342025-04-30Nexus Spine, LLCStable-L Lumbar Interbody SystemPDF
K2433862025-04-22Acuity Surgical Devices, LLCVentris Intervertebral Body Fusion DevicePDF
K2506032025-03-24InnovasisAxTiHA® Stand-Alone ALIF SystemPDF
K2438022025-03-17Carlsmed, Inc.aprevo® anterior and lateral lumbar interbody fusion…PDF
K2436352024-12-13Carlsmed, Inc.aprevo® anterior lumbar interbody fusion device with…PDF
K2431912024-11-26Atlas Spine, Inc.Atlas Spine Lateral Expandable Interbody System—
K2410772024-10-29Degen MedicalDeGen Medical Patient Specific Implant (PSI) SystemFDA
K2419922024-10-28Medtronic Sofamor Danek USA, Inc.Catalyft™ LS Expandable Interbody SystemPDF
K2414772024-10-09Carlsmed, Inc.aprevo® anterior lumbar interbody fusion device with…PDF
K2414872024-10-02Foundation Surgical Group, Inc.Interwedge® Standalone LateralPDF
K2413212024-07-18Spineart SAJuliet® Ti LL Lumbar Interbody DevicePDF
K2403682024-05-15Evolution SpineE3D™-A Interbody SystemPDF
K2401262024-05-03Pro Surgical, Inc.ProAM ALIF SystemPDF
K2406232024-04-24Omnia Medical, LLCOmnia Medical TiBrid™-SA SystemPDF
K2339662024-04-224Web Medical, Inc.Anterior Spine Truss System-Stand Alone (ASTS-SA)PDF
K2324322024-01-30Evolution SpineE3D™-A Interbody SystemPDF
K2321232023-10-18Medacta International S.A.MectaLIF Anterior Lag ExtensionPDF
K2314862023-10-12Nexus Spine, LLCStable-L Standalone Lumbar Interbody SystemPDF
K2320972023-09-25Alphatec Spine, Inc.IdentiTi ALIF Interbody SystemsPDF
K2325302023-09-18Nexus Spine, LLCStable-L Standalone Lumbar Interbody System, Stable-…FDA
K2321542023-09-11MiRus, LLCMiRus 3DR Lateral Lumbar Interbody Fusion System wit…PDF

其中 29 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: 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。