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Panels › Orthopedic › Product code MAX · Class 2

Intervertebral Fusion Device With Bone Graft, Lumbar

Regulation 888.3080

20510(k)s in 12 months (897 all time)
5recalls in 12 months (116 all time)
105recalls that name a 510(k)
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Top companies in MAX

Company510(k)sRecalls
Medtronic Sofamor Danek5512
Globus Medical, Inc.2022
Nu Vasive, Incorporated340
Life Spine330
Alphatec Spine223
Spineology, Inc.220
SeaSpine Orthopedics Corporation201
Spinal Elements172
Stryker170
K2m133
Decided510(k)Device and applicantCode
Oct 21, 2026K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody Syst
Alphatec Spine, Inc.
MAX
Aug 20, 2026K261049SCALA® TL
Spineart SA, CH
MAX
Jul 28, 2026K261430TruLift Expandable System
Life Spine, Inc.
MAX
Jul 17, 2026K253011Catalyft PL Expandable Interbody System
Medtronic Sofamor Danek USA, Inc.
MAX
Jul 14, 2026K261020Symmetrix™ L Spinal System
Medtronic Sofamor Danek USA, Inc.
MAX
Jul 1, 2026K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian A
SeaSpine Orthopedics Corporation
MAX
Jun 15, 2026K253151Fule Interbody Fusion Cage System
Beijing Fule Science & Technology Development Co., Ltd., CN
MAX
May 29, 2026K261159Exceed® Biplanar Expandable Interbody System
Spine Wave, Inc.
MAX
May 28, 2026K253894BMD Titanium Spinal Fusion System
Global Biomedica s.r.o., CZ
MAX
May 15, 2026K260506Ventana® P/T Lumbar Interbody System
Spinal Elements, Inc.
MAX
May 12, 2026K260837VersaLift Expandable System
Life Spine, Inc.
MAX
May 9, 2026K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; apre
Carlsmed, Inc.
MAX
Apr 30, 2026K261067BEE PLIF Cage
NGMedical GmbH, DE
MAX
Feb 26, 2026K254017SWINGO-3D Lumbar Cage System
Implanet, FR
MAX
Feb 23, 2026K253583LUX Expandable Lumbar Interbody System
Xenix Medical
MAX
Feb 4, 2026K250773Luna® Ti Interbody Fusion System
Spinal Elements, Inc.
MAX
Jan 23, 2026K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System
Life Spine, Inc.
MAX
Jan 8, 2026K253266Titanium Interbody System
Spine Innovation, LLC
MAX
Dec 19, 2025K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)
Medicrea International S.A.S. (Medtronic), FR
MAX
Nov 25, 2025K252610ZSFab Lumbar Interbody System
Zsfab, Inc.
MAX
Oct 28, 2025K252351UniSpace® TPLIF Cage
Cg Medtech Co., Ltd., KR
MAX
Oct 24, 2025K253377Expandable Titanium PLIF/TLIF System
Spectrum Spine, Inc.
MAX
Sep 18, 2025K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbo
Mobarn Medical Devices, LLC
MAX
Sep 4, 2025K251444Endoskeleton™ Interbody Systems
Medtronic Sofamor Danek USA, Inc.
MAX
Aug 15, 2025K251969Atlas Spine Project X Expandable Posterior Lumbar Interbody System
Atlas Spine, Inc.
MAX
Aug 5, 2025K252113PRADO™ Lumbar Interbody Fusion System
Bethesda Medical Devices
MAX
Jul 17, 2025K251016MectaLIF 3D Metal
Medacta International S.A., CH
MAX
Jul 8, 2025K251741PathLoc Lumbar Interbody Fusion Cage System
L&K BIOMED Co., Ltd., KR
MAX
Jul 7, 2025K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System
Life Spine, Inc.
MAX
Jul 7, 2025K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar
Carlsmed, Inc.
MAX
Jun 30, 2025K250987aprevo® posterior/transforaminal lumbar interbody fusion device
Carlsmed, Inc.
MAX
Jun 27, 2025K243816Testa TP Pivoting Spacer System
Spine Wave, Inc.
MAX
Jun 25, 2025K251003X-PAC® LLIF Expandable Lateral Cage System
Expanding Innovations, Inc.
MAX
Jun 16, 2025K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System
Expanding Innovations, Inc.
MAX
Jun 12, 2025K243973FIX-L PEEK PLIF and T-PLIF System
Jeil Medical Corporation, KR
MAX
Jun 2, 2025K251335Tera Lumbar Interbody Fusion System (Various PNs)
Acuity Surgical Devices, LLC
MAX
May 21, 2025K243116FlareHawk Interbody Fusion System
Integrity Implants Inc. Dba Accelus
MAX
Apr 22, 2025K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology
Medtronic Sofamor Danek USA, Inc.
MAX
Apr 9, 2025K250373ProLift Expandable Spacer System
Life Spine, Inc.
MAX
Apr 4, 2025K250667DeGen Medical Patient Specific Implant (PSI) System
Degen Medical
MAX
Apr 4, 2025K243074Spectrum Spine Lumbar Cage System
Spectrum Spine, Inc.
MAX
Mar 21, 2025K250186GoLIF! Lumbar Interbody Fusion System
Getset Surgical, SA, CH
MAX
Mar 20, 2025K242771Tesera-k PL System and Tesera-k XL System
Kyocera Medical Technologies, Inc.
MAX
Mar 18, 2025K241783FortiVy™ OsteoVy™ Lumbar IBF
Vy Spine, LLC
MAX
Feb 3, 2025K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; Id
Alphatec Spine
MAX
Jan 24, 2025K243739AxCess® Expandable Interbody System
Elliquence, LLC
MAX
Jan 23, 2025K243668ProLift Pivot Expandable Spacer System
Life Spine, Inc.
MAX
Dec 31, 2024K243670Idys® LIF
Clariance, FR
MAX
Dec 6, 2024K241073DZ-Tabone Intervertebral Body Fusion Device
Shenzhen Dazhou Medical Technology Co., Ltd., CN
MAX
Oct 23, 2024K242829BluEX Lumbar Expandable Cage System
L&K BIOMED Co., Ltd., KR
MAX

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