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MAX

Intervertebral Fusion Device With Bone Graft, Lumbar

Product code
MAX
Device name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device class
Class 2
21 CFR
21 CFR 888.3080
Medical specialty
Orthopedic
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
896

FDA classification definition

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (90)

Last three years. Most recent: 2026-08-20.

NumberDecision dateApplicantDevice name
K2610492026-08-20Spineart SASCALA® TL summary
K2614302026-07-28Life Spine, Inc.TruLift Expandable System summary
K2530112026-07-17Medtronic Sofamor Danek USA, Inc.Catalyft PL Expandable Interbody System summary
K2610202026-07-14Medtronic Sofamor Danek USA, Inc.Symmetrix™ L Spinal System summary
K2534202026-07-01SeaSpine Orthopedics CorporationAdmiral ACP System; Explorer TO System; Laminoplasty summary
K2531512026-06-15Beijing Fule Science & Technology DeveFule Interbody Fusion Cage System summary
K2611592026-05-29Spine Wave, Inc.Exceed® Biplanar Expandable Interbody System summary
K2538942026-05-28Global Biomedica s.r.o.BMD Titanium Spinal Fusion System summary
K2605062026-05-15Spinal Elements, Inc.Ventana® P/T Lumbar Interbody System summary
K2608372026-05-12Life Spine, Inc.VersaLift Expandable System summary
K2603852026-05-09Carlsmed, Inc.aprevo® anterior and lateral lumbar interbody system summary
K2610672026-04-30NGMedical GmbHBEE PLIF Cage summary
K2540172026-02-26ImplanetSWINGO-3D Lumbar Cage System summary
K2535832026-02-23Xenix MedicalLUX Expandable Lumbar Interbody System summary
K2507732026-02-04Spinal Elements, Inc.Luna® Ti Interbody Fusion System summary
K2537482026-01-23Life Spine, Inc.Life Spine ProLift & ProLift Lateral and ProLift Lat summary
K2532662026-01-08Spine Innovation, LLCTitanium Interbody System summary
K2535772025-12-19Medicrea International S.A.S. (MedtronIB3D™ PL Spinal System (A24000000 / IB3D Universal I summary
K2526102025-11-25Zsfab, Inc.ZSFab Lumbar Interbody System summary
K2523512025-10-28Cg Medtech Co., Ltd.UniSpace® TPLIF Cage summary
K2533772025-10-24Spectrum Spine, Inc.Expandable Titanium PLIF/TLIF System summary
K2514792025-09-18Mobarn Medical Devices, LLCMobarn 80:20 Lumbar Interbody Fusion System (Posteri summary
K2514442025-09-04Medtronic Sofamor Danek USA, Inc.Endoskeleton™ Interbody Systems summary
K2519692025-08-15Atlas Spine, Inc.Atlas Spine Project X Expandable Posterior Lumbar In
K2521132025-08-05Bethesda Medical DevicesPRADO™ Lumbar Interbody Fusion System summary
K2510162025-07-17Medacta International S.A.MectaLIF 3D Metal summary
K2517412025-07-08L&K BIOMED Co., Ltd.PathLoc Lumbar Interbody Fusion Cage System summary
K2508272025-07-07Carlsmed, Inc.aprevo® anterior lumbar interbody fusion device; apr summary
K2515022025-07-07Life Spine, Inc.TruLift® Lateral Expandable Spacer & Lateral Buttres summary
K2509872025-06-30Carlsmed, Inc.aprevo® posterior/transforaminal lumbar interbody fu summary
K2438162025-06-27Spine Wave, Inc.Testa TP Pivoting Spacer System summary
K2510032025-06-25Expanding Innovations, Inc.X-PAC® LLIF Expandable Lateral Cage System summary
K2516172025-06-16Expanding Innovations, Inc.X-PAC® TLIF Expandable Posterior Cage System; X-PAC® summary
K2439732025-06-12Jeil Medical CorporationFIX-L PEEK PLIF and T-PLIF System summary
K2513352025-06-02Acuity Surgical Devices, LLCTera Lumbar Interbody Fusion System (Various PNs) summary
K2431162025-05-21Integrity Implants Inc. Dba AccelusFlareHawk Interbody Fusion System summary
K2506692025-04-22Medtronic Sofamor Danek USA, Inc.Adaptix™ Interbody System with Titan nanoLOCK™ Surfa summary
K2503732025-04-09Life Spine, Inc.ProLift Expandable Spacer System summary
K2430742025-04-04Spectrum Spine, Inc.Spectrum Spine Lumbar Cage System summary
K2506672025-04-04Degen MedicalDeGen Medical Patient Specific Implant (PSI) System summary
K2501862025-03-21Getset Surgical, SAGoLIF! Lumbar Interbody Fusion System summary
K2427712025-03-20Kyocera Medical Technologies, Inc.Tesera-k PL System and Tesera-k XL System summary
K2417832025-03-18Vy Spine, LLCFortiVy™ OsteoVy™ Lumbar IBF summary
K2413752025-02-03Alphatec SpineIdentiTi Porous Ti Interbody System; IdentiTi NanoTe summary
K2437392025-01-24Elliquence, LLCAxCess® Expandable Interbody System summary
K2436682025-01-23Life Spine, Inc.ProLift Pivot Expandable Spacer System summary
K2436702024-12-31ClarianceIdys® LIF summary
K2410732024-12-06Shenzhen Dazhou Medical Technology Co.DZ-Tabone Intervertebral Body Fusion Device summary
K2428292024-10-23L&K BIOMED Co., Ltd.BluEX Lumbar Expandable Cage System summary
K2425892024-10-23Spineart SAScarlet® AL-T summary
K2339472024-10-10Ctl Medical CorporationKLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage summary
K2428262024-10-08Life Spine, Inc.ProLift Wedge Expandable Spacer System summary
K2422672024-10-08ZheJiang Decans Medical Devices Co., LGemini Medical Cage System summary
K2424572024-10-07Retropsoas Technologies, LLCEARP Interbody System summary
K2423642024-10-04Alphatec Spine, Inc.IdentiTi™ II Interbody System summary
K2408892024-10-02Artfx MedicalARTFX Lumbar PEEK Cages summary
K2338072024-09-24Vy Spine, LLCLumiVy™ Lumbar IBF System summary
K2413322024-09-20Carlsmed, Inc.aprevo® anterior and lateral lumbar interbody fusion summary
K2421472024-09-20Alphatec Spine, Inc.Calibrate LTX Interbody System; Calibrate NanoTec LT summary
K2425092024-09-19Next OrthosurgicalHAnano InterFuse(R) Modular Interbody summary
K2402502024-09-17Nvision Biomedical Technologies, Inc.3D Printed PEEK Interbody System summary
K2414382024-09-11Signus Medizintechnik GmbHSignus Tetris™ St; Signus Tetris™ R St summary
K2340352024-09-06Globus Medical, Inc.COSINE™ Spacer summary
K2329962024-09-06Shanghai Iatrical-Ti Technologies CO ,Iatrical Interbody Lumbar Fusion Systems (Model ALI summary
K2411642024-09-06Medicrea International S.A.S. (MedtronIB3D™ PL Spinal System summary
K2416052024-09-05Nanovis, LLCAdaptix™ PEEK Interbody System with Nanotechnology; summary
K2413282024-08-12Carlsmed, Inc.aprevo® Anterior and Lateral Lumbar Interbody Fusion summary
K2403262024-07-29Degen Medical, Inc.Solar™ Lumbar Interbody Fusion System summary
K2414132024-07-17Acuity Surgical Devices, LLCsagAlign Lumbar Cage System (Various PNs) summary
K2340772024-07-12Camber Spine TechnologiesSPIRA® Anterior Lumbar Spacers summary
K2410192024-07-09Carlsmedaprevo® TLIF-C Articulating System summary
K2414662024-06-20SeaSpine Orthopedics CorporationShoreline ACS Interbody System; Shoreline RT Interbo summary
K2408302024-06-20Orthofix Medical, Inc.Reef TO/TA System; Regatta Lateral System; Explorer summary
K2407492024-05-28Orthofix, Inc.PILLAR SA Ti Spacer System (82-XXX) summary
K2405662024-04-26SeaSpine Orthopedics CorporationReef L Interbody System; WaveForm L Interbody System summary
K2335092024-04-10Zavation Medical Products, LLCZavation IBF System, Zavation Varisync Plate System summary
K2327922024-04-05Icotec AGicotec Interbody Cage System (icotec Cervical Cage, summary
K2341502024-03-27Spinal ElementsLucent® XP summary
K2322822024-03-22Carlsmed, Inc.aprevo® anterior and lateral lumbar interbody fusion summary
K2333752024-03-20Nexus Spine, LLCTranquil-L Interbody System summary
K2330752024-03-06Biogend Therapeutics Co., Ltd.“BioGend” Interbody Fusion System 001 Cage summary
K2340872024-01-22Restor3Drestor3d TIDAL Lumbar Interbody Fusion System summary
K2337442024-01-18Curiteva, Inc.Curiteva Porous PEEK Lumbar Interbody Fusion System summary
K2336942024-01-12SeaSpine Orthopedics CorporationMeridian Interbody System; WaveForm A Interbody Syst summary
K2308722023-12-12Shanghai Sanyou Medical Co, Ltd.Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fu summary
K2317432023-12-08Corelink, LLCF3D Lateral Lumbar Interbody System, CL5 Lateral Lum summary
K2326112023-11-30Life Spine, Inc.TruLift Micro Expandable Spacer System & TruLift Exp summary
K2320692023-11-29Shanghai Reach Medical Instrument Co, Expandable Lumbar Fusion Cage (Type I,Type II) summary
K2322922023-11-07Gbs Commonwealth Co., Ltd.Peridot-EX Expandable Intervertebral Body Fusion Sys summary
K2325042023-10-13Alphatec Spine, Inc.Calibrate CCX Interbody System summary
Official FDA classification page: MAX
Classification and pathway per current FDA publications. Data from openFDA (CC0).