MAX
- 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)
- 896 件
FDA 分类定义
Intended to stabilize 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)（90 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K261049 | 2026-08-20 | Spineart SA | SCALA® TL 摘要 |
| K261430 | 2026-07-28 | Life Spine, Inc. | TruLift Expandable System 摘要 |
| K253011 | 2026-07-17 | Medtronic Sofamor Danek USA, Inc. | Catalyft PL Expandable Interbody System 摘要 |
| K261020 | 2026-07-14 | Medtronic Sofamor Danek USA, Inc. | Symmetrix L Spinal System 摘要 |
| K253420 | 2026-07-01 | SeaSpine Orthopedics Corporation | Admiral ACP System; Explorer TO System; Laminoplasty 摘要 |
| K253151 | 2026-06-15 | Beijing Fule Science & Technology Deve | Fule Interbody Fusion Cage System 摘要 |
| K261159 | 2026-05-29 | Spine Wave, Inc. | Exceed® Biplanar Expandable Interbody System 摘要 |
| K253894 | 2026-05-28 | Global Biomedica s.r.o. | BMD Titanium Spinal Fusion System 摘要 |
| K260506 | 2026-05-15 | Spinal Elements, Inc. | Ventana® P/T Lumbar Interbody System 摘要 |
| K260837 | 2026-05-12 | Life Spine, Inc. | VersaLift Expandable System 摘要 |
| K260385 | 2026-05-09 | Carlsmed, Inc. | aprevo® anterior and lateral lumbar interbody system 摘要 |
| K261067 | 2026-04-30 | NGMedical GmbH | BEE PLIF Cage 摘要 |
| K254017 | 2026-02-26 | Implanet | SWINGO-3D Lumbar Cage System 摘要 |
| K253583 | 2026-02-23 | Xenix Medical | LUX Expandable Lumbar Interbody System 摘要 |
| K250773 | 2026-02-04 | Spinal Elements, Inc. | Luna® Ti Interbody Fusion System 摘要 |
| K253748 | 2026-01-23 | Life Spine, Inc. | Life Spine ProLift & ProLift Lateral and ProLift Lat 摘要 |
| K253266 | 2026-01-08 | Spine Innovation, LLC | Titanium Interbody System 摘要 |
| K253577 | 2025-12-19 | Medicrea International S.A.S. (Medtron | IB3D PL Spinal System (A24000000 / IB3D Universal I 摘要 |
| K252610 | 2025-11-25 | Zsfab, Inc. | ZSFab Lumbar Interbody System 摘要 |
| K252351 | 2025-10-28 | Cg Medtech Co., Ltd. | UniSpace® TPLIF Cage 摘要 |
| K253377 | 2025-10-24 | Spectrum Spine, Inc. | Expandable Titanium PLIF/TLIF System 摘要 |
| K251479 | 2025-09-18 | Mobarn Medical Devices, LLC | Mobarn 80:20 Lumbar Interbody Fusion System (Posteri 摘要 |
| K251444 | 2025-09-04 | Medtronic Sofamor Danek USA, Inc. | Endoskeleton Interbody Systems 摘要 |
| K251969 | 2025-08-15 | Atlas Spine, Inc. | Atlas Spine Project X Expandable Posterior Lumbar In |
| K252113 | 2025-08-05 | Bethesda Medical Devices | PRADO Lumbar Interbody Fusion System 摘要 |
| K251016 | 2025-07-17 | Medacta International S.A. | MectaLIF 3D Metal 摘要 |
| K251741 | 2025-07-08 | L&K BIOMED Co., Ltd. | PathLoc Lumbar Interbody Fusion Cage System 摘要 |
| K250827 | 2025-07-07 | Carlsmed, Inc. | aprevo® anterior lumbar interbody fusion device; apr 摘要 |
| K251502 | 2025-07-07 | Life Spine, Inc. | TruLift® Lateral Expandable Spacer & Lateral Buttres 摘要 |
| K250987 | 2025-06-30 | Carlsmed, Inc. | aprevo® posterior/transforaminal lumbar interbody fu 摘要 |
| K243816 | 2025-06-27 | Spine Wave, Inc. | Testa TP Pivoting Spacer System 摘要 |
| K251003 | 2025-06-25 | Expanding Innovations, Inc. | X-PAC® LLIF Expandable Lateral Cage System 摘要 |
| K251617 | 2025-06-16 | Expanding Innovations, Inc. | X-PAC® TLIF Expandable Posterior Cage System; X-PAC® 摘要 |
| K243973 | 2025-06-12 | Jeil Medical Corporation | FIX-L PEEK PLIF and T-PLIF System 摘要 |
| K251335 | 2025-06-02 | Acuity Surgical Devices, LLC | Tera Lumbar Interbody Fusion System (Various PNs) 摘要 |
| K243116 | 2025-05-21 | Integrity Implants Inc. Dba Accelus | FlareHawk Interbody Fusion System 摘要 |
| K250669 | 2025-04-22 | Medtronic Sofamor Danek USA, Inc. | Adaptix Interbody System with Titan nanoLOCK Surfa 摘要 |
| K250373 | 2025-04-09 | Life Spine, Inc. | ProLift Expandable Spacer System 摘要 |
| K243074 | 2025-04-04 | Spectrum Spine, Inc. | Spectrum Spine Lumbar Cage System 摘要 |
| K250667 | 2025-04-04 | Degen Medical | DeGen Medical Patient Specific Implant (PSI) System 摘要 |
| K250186 | 2025-03-21 | Getset Surgical, SA | GoLIF! Lumbar Interbody Fusion System 摘要 |
| K242771 | 2025-03-20 | Kyocera Medical Technologies, Inc. | Tesera-k PL System and Tesera-k XL System 摘要 |
| K241783 | 2025-03-18 | Vy Spine, LLC | FortiVy OsteoVy Lumbar IBF 摘要 |
| K241375 | 2025-02-03 | Alphatec Spine | IdentiTi Porous Ti Interbody System; IdentiTi NanoTe 摘要 |
| K243739 | 2025-01-24 | Elliquence, LLC | AxCess® Expandable Interbody System 摘要 |
| K243668 | 2025-01-23 | Life Spine, Inc. | ProLift Pivot Expandable Spacer System 摘要 |
| K243670 | 2024-12-31 | Clariance | Idys® LIF 摘要 |
| K241073 | 2024-12-06 | Shenzhen Dazhou Medical Technology Co. | DZ-Tabone Intervertebral Body Fusion Device 摘要 |
| K242829 | 2024-10-23 | L&K BIOMED Co., Ltd. | BluEX Lumbar Expandable Cage System 摘要 |
| K242589 | 2024-10-23 | Spineart SA | Scarlet® AL-T 摘要 |
| K233947 | 2024-10-10 | Ctl Medical Corporation | KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage 摘要 |
| K242826 | 2024-10-08 | Life Spine, Inc. | ProLift Wedge Expandable Spacer System 摘要 |
| K242267 | 2024-10-08 | ZheJiang Decans Medical Devices Co., L | Gemini Medical Cage System 摘要 |
| K242457 | 2024-10-07 | Retropsoas Technologies, LLC | EARP Interbody System 摘要 |
| K242364 | 2024-10-04 | Alphatec Spine, Inc. | IdentiTi II Interbody System 摘要 |
| K240889 | 2024-10-02 | Artfx Medical | ARTFX Lumbar PEEK Cages 摘要 |
| K233807 | 2024-09-24 | Vy Spine, LLC | LumiVy Lumbar IBF System 摘要 |
| K241332 | 2024-09-20 | Carlsmed, Inc. | aprevo® anterior and lateral lumbar interbody fusion 摘要 |
| K242147 | 2024-09-20 | Alphatec Spine, Inc. | Calibrate LTX Interbody System; Calibrate NanoTec LT 摘要 |
| K242509 | 2024-09-19 | Next Orthosurgical | HAnano InterFuse(R) Modular Interbody 摘要 |
| K240250 | 2024-09-17 | Nvision Biomedical Technologies, Inc. | 3D Printed PEEK Interbody System 摘要 |
| K241438 | 2024-09-11 | Signus Medizintechnik GmbH | Signus Tetris St; Signus Tetris R St 摘要 |
| K234035 | 2024-09-06 | Globus Medical, Inc. | COSINE Spacer 摘要 |
| K232996 | 2024-09-06 | Shanghai Iatrical-Ti Technologies CO , | Iatrical Interbody Lumbar Fusion Systems (Model ALI 摘要 |
| K241164 | 2024-09-06 | Medicrea International S.A.S. (Medtron | IB3D PL Spinal System 摘要 |
| K241605 | 2024-09-05 | Nanovis, LLC | Adaptix PEEK Interbody System with Nanotechnology; 摘要 |
| K241328 | 2024-08-12 | Carlsmed, Inc. | aprevo® Anterior and Lateral Lumbar Interbody Fusion 摘要 |
| K240326 | 2024-07-29 | Degen Medical, Inc. | Solar Lumbar Interbody Fusion System 摘要 |
| K241413 | 2024-07-17 | Acuity Surgical Devices, LLC | sagAlign Lumbar Cage System (Various PNs) 摘要 |
| K234077 | 2024-07-12 | Camber Spine Technologies | SPIRA® Anterior Lumbar Spacers 摘要 |
| K241019 | 2024-07-09 | Carlsmed | aprevo® TLIF-C Articulating System 摘要 |
| K241466 | 2024-06-20 | SeaSpine Orthopedics Corporation | Shoreline ACS Interbody System; Shoreline RT Interbo 摘要 |
| K240830 | 2024-06-20 | Orthofix Medical, Inc. | Reef TO/TA System; Regatta Lateral System; Explorer 摘要 |
| K240749 | 2024-05-28 | Orthofix, Inc. | PILLAR SA Ti Spacer System (82-XXX) 摘要 |
| K240566 | 2024-04-26 | SeaSpine Orthopedics Corporation | Reef L Interbody System; WaveForm L Interbody System 摘要 |
| K233509 | 2024-04-10 | Zavation Medical Products, LLC | Zavation IBF System, Zavation Varisync Plate System 摘要 |
| K232792 | 2024-04-05 | Icotec AG | icotec Interbody Cage System (icotec Cervical Cage, 摘要 |
| K234150 | 2024-03-27 | Spinal Elements | Lucent® XP 摘要 |
| K232282 | 2024-03-22 | Carlsmed, Inc. | aprevo® anterior and lateral lumbar interbody fusion 摘要 |
| K233375 | 2024-03-20 | Nexus Spine, LLC | Tranquil-L Interbody System 摘要 |
| K233075 | 2024-03-06 | Biogend Therapeutics Co., Ltd. | BioGend Interbody Fusion System 001 Cage 摘要 |
| K234087 | 2024-01-22 | Restor3D | restor3d TIDAL Lumbar Interbody Fusion System 摘要 |
| K233744 | 2024-01-18 | Curiteva, Inc. | Curiteva Porous PEEK Lumbar Interbody Fusion System 摘要 |
| K233694 | 2024-01-12 | SeaSpine Orthopedics Corporation | Meridian Interbody System; WaveForm A Interbody Syst 摘要 |
| K230872 | 2023-12-12 | Shanghai Sanyou Medical Co, Ltd. | Halis Lumbar Cage System, Lydia Anterior Lumbar Fu 摘要 |
| K231743 | 2023-12-08 | Corelink, LLC | F3D Lateral Lumbar Interbody System, CL5 Lateral Lum 摘要 |
| K232611 | 2023-11-30 | Life Spine, Inc. | TruLift Micro Expandable Spacer System & TruLift Exp 摘要 |
| K232069 | 2023-11-29 | Shanghai Reach Medical Instrument Co, | Expandable Lumbar Fusion Cage (Type I,Type II) 摘要 |
| K232292 | 2023-11-07 | Gbs Commonwealth Co., Ltd. | Peridot-EX Expandable Intervertebral Body Fusion Sys 摘要 |
| K232504 | 2023-10-13 | Alphatec Spine, Inc. | Calibrate CCX Interbody System 摘要 |
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。