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MAX

Intervertebral Fusion Device With Bone Graft, Lumbar

产品代码
MAX
器械名称
Intervertebral Fusion Device With Bone Graft, 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)
90 件
其中 Summary 已存档
76 份,可直接下载
FDA 历史累计 510(k)
896 件(全部年份;本站只收录近三年的明细)

FDA 分类定义

Intended to stabilize 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)(90 件)

数据窗口为最近三年。最新一件:2026-08-20。

510(k) 号批准日期申请人器械名称摘要
K2610492026-08-20Spineart SASCALA® TLPDF
K2614302026-07-28Life Spine, Inc.TruLift Expandable SystemPDF
K2530112026-07-17Medtronic Sofamor Danek USA, Inc.Catalyft PL Expandable Interbody SystemPDF
K2610202026-07-14Medtronic Sofamor Danek USA, Inc.Symmetrix™ L Spinal SystemPDF
K2534202026-07-01SeaSpine Orthopedics CorporationAdmiral ACP System; Explorer TO System; Laminoplasty…PDF
K2531512026-06-15Beijing Fule Science & Technology Deve…Fule Interbody Fusion Cage SystemFDA
K2611592026-05-29Spine Wave, Inc.Exceed® Biplanar Expandable Interbody SystemFDA
K2538942026-05-28Global Biomedica s.r.o.BMD Titanium Spinal Fusion SystemPDF
K2605062026-05-15Spinal Elements, Inc.Ventana® P/T Lumbar Interbody SystemPDF
K2608372026-05-12Life Spine, Inc.VersaLift Expandable SystemPDF
K2603852026-05-09Carlsmed, Inc.aprevo® anterior and lateral lumbar interbody system…PDF
K2610672026-04-30NGMedical GmbHBEE PLIF CagePDF
K2540172026-02-26ImplanetSWINGO-3D Lumbar Cage SystemPDF
K2535832026-02-23Xenix MedicalLUX Expandable Lumbar Interbody SystemPDF
K2507732026-02-04Spinal Elements, Inc.Luna® Ti Interbody Fusion SystemPDF
K2537482026-01-23Life Spine, Inc.Life Spine ProLift & ProLift Lateral and ProLift Lat…PDF
K2532662026-01-08Spine Innovation, LLCTitanium Interbody SystemPDF
K2535772025-12-19Medicrea International S.A.S. (Medtron…IB3D™ PL Spinal System (A24000000 / IB3D Universal I…FDA
K2526102025-11-25Zsfab, Inc.ZSFab Lumbar Interbody SystemPDF
K2523512025-10-28Cg Medtech Co., Ltd.UniSpace® TPLIF CagePDF
K2533772025-10-24Spectrum Spine, Inc.Expandable Titanium PLIF/TLIF SystemPDF
K2514792025-09-18Mobarn Medical Devices, LLCMobarn 80:20 Lumbar Interbody Fusion System (Posteri…FDA
K2514442025-09-04Medtronic Sofamor Danek USA, Inc.Endoskeleton™ Interbody SystemsPDF
K2519692025-08-15Atlas Spine, Inc.Atlas Spine Project X Expandable Posterior Lumbar In…—
K2521132025-08-05Bethesda Medical DevicesPRADO™ Lumbar Interbody Fusion SystemPDF
K2510162025-07-17Medacta International S.A.MectaLIF 3D MetalPDF
K2517412025-07-08L&K BIOMED Co., Ltd.PathLoc Lumbar Interbody Fusion Cage SystemPDF
K2508272025-07-07Carlsmed, Inc.aprevo® anterior lumbar interbody fusion device; apr…PDF
K2515022025-07-07Life Spine, Inc.TruLift® Lateral Expandable Spacer & Lateral Buttres…PDF
K2509872025-06-30Carlsmed, Inc.aprevo® posterior/transforaminal lumbar interbody fu…PDF
K2438162025-06-27Spine Wave, Inc.Testa TP Pivoting Spacer SystemPDF
K2510032025-06-25Expanding Innovations, Inc.X-PAC® LLIF Expandable Lateral Cage SystemPDF
K2516172025-06-16Expanding Innovations, Inc.X-PAC® TLIF Expandable Posterior Cage System; X-PAC®…PDF
K2439732025-06-12Jeil Medical CorporationFIX-L PEEK PLIF and T-PLIF SystemPDF
K2513352025-06-02Acuity Surgical Devices, LLCTera Lumbar Interbody Fusion System (Various PNs)PDF
K2431162025-05-21Integrity Implants Inc. Dba AccelusFlareHawk Interbody Fusion SystemPDF
K2506692025-04-22Medtronic Sofamor Danek USA, Inc.Adaptix™ Interbody System with Titan nanoLOCK™ Surfa…PDF
K2503732025-04-09Life Spine, Inc.ProLift Expandable Spacer SystemPDF
K2430742025-04-04Spectrum Spine, Inc.Spectrum Spine Lumbar Cage SystemPDF
K2506672025-04-04Degen MedicalDeGen Medical Patient Specific Implant (PSI) SystemPDF
K2501862025-03-21Getset Surgical, SAGoLIF! Lumbar Interbody Fusion SystemPDF
K2427712025-03-20Kyocera Medical Technologies, Inc.Tesera-k PL System and Tesera-k XL SystemPDF
K2417832025-03-18Vy Spine, LLCFortiVy™ OsteoVy™ Lumbar IBFPDF
K2413752025-02-03Alphatec SpineIdentiTi Porous Ti Interbody System; IdentiTi NanoTe…PDF
K2437392025-01-24Elliquence, LLCAxCess® Expandable Interbody SystemPDF
K2436682025-01-23Life Spine, Inc.ProLift Pivot Expandable Spacer SystemPDF
K2436702024-12-31ClarianceIdys® LIFPDF
K2410732024-12-06Shenzhen Dazhou Medical Technology Co.…DZ-Tabone Intervertebral Body Fusion DevicePDF
K2428292024-10-23L&K BIOMED Co., Ltd.BluEX Lumbar Expandable Cage SystemPDF
K2425892024-10-23Spineart SAScarlet® AL-TPDF
K2339472024-10-10Ctl Medical CorporationKLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage…PDF
K2428262024-10-08Life Spine, Inc.ProLift Wedge Expandable Spacer SystemPDF
K2422672024-10-08ZheJiang Decans Medical Devices Co., L…Gemini Medical Cage SystemPDF
K2424572024-10-07Retropsoas Technologies, LLCEARP Interbody SystemFDA
K2423642024-10-04Alphatec Spine, Inc.IdentiTi™ II Interbody SystemPDF
K2408892024-10-02Artfx MedicalARTFX Lumbar PEEK CagesPDF
K2338072024-09-24Vy Spine, LLCLumiVy™ Lumbar IBF SystemFDA
K2413322024-09-20Carlsmed, Inc.aprevo® anterior and lateral lumbar interbody fusion…PDF
K2421472024-09-20Alphatec Spine, Inc.Calibrate LTX Interbody System; Calibrate NanoTec LT…FDA
K2425092024-09-19Next OrthosurgicalHAnano InterFuse(R) Modular InterbodyPDF
K2402502024-09-17Nvision Biomedical Technologies, Inc.3D Printed PEEK Interbody SystemPDF
K2414382024-09-11Signus Medizintechnik GmbHSignus Tetris™ St; Signus Tetris™ R StPDF
K2340352024-09-06Globus Medical, Inc.COSINE™ SpacerPDF
K2329962024-09-06Shanghai Iatrical-Ti Technologies CO ,…Iatrical Interbody Lumbar Fusion Systems (Model ALI…PDF
K2411642024-09-06Medicrea International S.A.S. (Medtron…IB3D™ PL Spinal SystemFDA
K2416052024-09-05Nanovis, LLCAdaptix™ PEEK Interbody System with Nanotechnology; …PDF
K2413282024-08-12Carlsmed, Inc.aprevo® Anterior and Lateral Lumbar Interbody Fusion…PDF
K2403262024-07-29Degen Medical, Inc.Solar™ Lumbar Interbody Fusion SystemFDA
K2414132024-07-17Acuity Surgical Devices, LLCsagAlign Lumbar Cage System (Various PNs)PDF
K2340772024-07-12Camber Spine TechnologiesSPIRA® Anterior Lumbar SpacersPDF
K2410192024-07-09Carlsmedaprevo® TLIF-C Articulating SystemPDF
K2414662024-06-20SeaSpine Orthopedics CorporationShoreline ACS Interbody System; Shoreline RT Interbo…PDF
K2408302024-06-20Orthofix Medical, Inc.Reef TO/TA System; Regatta Lateral System; Explorer …FDA
K2407492024-05-28Orthofix, Inc.PILLAR SA Ti Spacer System (82-XXX)PDF
K2405662024-04-26SeaSpine Orthopedics CorporationReef L Interbody System; WaveForm L Interbody SystemPDF
K2335092024-04-10Zavation Medical Products, LLCZavation IBF System, Zavation Varisync Plate System …FDA
K2327922024-04-05Icotec AGicotec Interbody Cage System (icotec Cervical Cage, …PDF
K2341502024-03-27Spinal ElementsLucent® XPPDF
K2322822024-03-22Carlsmed, Inc.aprevo® anterior and lateral lumbar interbody fusion…FDA
K2333752024-03-20Nexus Spine, LLCTranquil-L Interbody SystemPDF
K2330752024-03-06Biogend Therapeutics Co., Ltd.“BioGend” Interbody Fusion System 001 CagePDF
K2340872024-01-22Restor3Drestor3d TIDAL Lumbar Interbody Fusion SystemPDF
K2337442024-01-18Curiteva, Inc.Curiteva Porous PEEK Lumbar Interbody Fusion SystemPDF
K2336942024-01-12SeaSpine Orthopedics CorporationMeridian Interbody System; WaveForm A Interbody Syst…PDF
K2308722023-12-12Shanghai Sanyou Medical Co, Ltd.Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fu…PDF
K2317432023-12-08Corelink, LLCF3D Lateral Lumbar Interbody System, CL5 Lateral Lum…PDF
K2326112023-11-30Life Spine, Inc.TruLift Micro Expandable Spacer System & TruLift Exp…PDF
K2320692023-11-29Shanghai Reach Medical Instrument Co, …Expandable Lumbar Fusion Cage (Type I,Type II)PDF
K2322922023-11-07Gbs Commonwealth Co., Ltd.Peridot-EX Expandable Intervertebral Body Fusion Sys…FDA
K2325042023-10-13Alphatec Spine, Inc.Calibrate CCX Interbody SystemPDF

其中 76 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: MAX
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。