ClearanceBrief
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)
Get daily alerts for MAXSample briefCSV

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 23, 2024K242589Scarlet® AL-T
Spineart SA, CH
MAX
Oct 10, 2024K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System
Ctl Medical Corporation
MAX
Oct 8, 2024K242826ProLift Wedge Expandable Spacer System
Life Spine, Inc.
MAX
Oct 8, 2024K242267Gemini Medical Cage System
ZheJiang Decans Medical Devices Co., Ltd., CN
MAX
Oct 7, 2024K242457EARP Interbody System
Retropsoas Technologies, LLC
MAX
Oct 4, 2024K242364IdentiTi™ II Interbody System
Alphatec Spine, Inc.
MAX
Oct 2, 2024K240889ARTFX Lumbar PEEK Cages
Artfx Medical
MAX
Sep 24, 2024K233807LumiVy™ Lumbar IBF System
Vy Spine, LLC
MAX
Sep 20, 2024K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System
Alphatec Spine, Inc.
MAX
Sep 20, 2024K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with inter
Carlsmed, Inc.
MAX
Sep 19, 2024K242509HAnano InterFuse(R) Modular Interbody
Next Orthosurgical
MAX
Sep 17, 2024K2402503D Printed PEEK Interbody System
Nvision Biomedical Technologies, Inc.
MAX
Sep 11, 2024K241438Signus Tetris™ St; Signus Tetris™ R St
Signus Medizintechnik GmbH, DE
MAX
Sep 6, 2024K241164IB3D™ PL Spinal System
Medicrea International S.A.S. (Medtronic), FR
MAX
Sep 6, 2024K234035COSINE™ Spacer
Globus Medical, Inc.
MAX
Sep 6, 2024K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)
Shanghai Iatrical-Ti Technologies CO , Ltd., CN
MAX
Sep 5, 2024K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology
Nanovis, LLC
MAX
Aug 12, 2024K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo® Transforaminal Lumbar Interbody Fusion
Carlsmed, Inc.
MAX
Jul 29, 2024K240326Solar™ Lumbar Interbody Fusion System
Degen Medical, Inc.
MAX
Jul 17, 2024K241413sagAlign Lumbar Cage System (Various PNs)
Acuity Surgical Devices, LLC
MAX
Jul 12, 2024K234077SPIRA® Anterior Lumbar Spacers
Camber Spine Technologies
MAX
Jul 9, 2024K241019aprevo® TLIF-C Articulating System
Carlsmed
MAX
Jun 20, 2024K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/
SeaSpine Orthopedics Corporation
MAX
Jun 20, 2024K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System
Orthofix Medical, Inc.
MAX
May 28, 2024K240749PILLAR SA Ti Spacer System (82-XXX)
Orthofix, Inc.
MAX
Apr 26, 2024K240566Reef L Interbody System; WaveForm L Interbody System
SeaSpine Orthopedics Corporation
MAX
Apr 10, 2024K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System
Zavation Medical Products, LLC
MAX
Apr 5, 2024K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage)
Icotec AG, CH
MAX
Mar 27, 2024K234150Lucent® XP
Spinal Elements
MAX
Mar 22, 2024K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device
Carlsmed, Inc.
MAX
Mar 20, 2024K233375Tranquil-L Interbody System
Nexus Spine, LLC
MAX
Mar 6, 2024K233075“BioGend” Interbody Fusion System 001 Cage
Biogend Therapeutics Co., Ltd., TW
MAX
Jan 22, 2024K234087restor3d TIDAL Lumbar Interbody Fusion System
Restor3D
MAX
Jan 18, 2024K233744Curiteva Porous PEEK Lumbar Interbody Fusion System
Curiteva, Inc.
MAX
Jan 12, 2024K233694Meridian Interbody System; WaveForm A Interbody System
SeaSpine Orthopedics Corporation
MAX
Dec 12, 2023K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE
Shanghai Sanyou Medical Co, Ltd., CN
MAX
Dec 8, 2023K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System
Corelink, LLC
MAX
Nov 30, 2023K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System
Life Spine, Inc.
MAX
Nov 29, 2023K232069Expandable Lumbar Fusion Cage (Type I,Type II)
Shanghai Reach Medical Instrument Co, Ltd., CN
MAX
Nov 7, 2023K232292Peridot-EX Expandable Intervertebral Body Fusion System
Gbs Commonwealth Co., Ltd., KR
MAX
Oct 13, 2023K232504Calibrate CCX Interbody System
Alphatec Spine, Inc.
MAX
Sep 1, 2023K232014CONDUIT™ ATP Inserters
Enztec Limited, NZ
MAX
Aug 24, 2023K231680AccelFix Lumbar Expandable Cage System
L&K BIOMED Co., Ltd., KR
MAX
Aug 3, 2023K221894Lumbar Expandable lnterbody Spacers -Additional Indications/Implants
Globus Medical, Inc.
MAX
Jul 25, 2023K231275Exceed™ Biplanar Expandable Interbody System
Spine Wave, Inc.
MAX
Jul 13, 2023K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System
Alphatec Spine, Inc.
MAX
Jul 12, 2023K231241NanoHive Medical Lumbar Interbody System
NanoHive Medical, LLC
MAX
Jul 11, 2023K230942SPIRA® Posterior Lumbar Spacers
Camber Spine Technologies
MAX
Jun 30, 2023K231252Ventana™ L Spinal System
Spinal Elements, Inc.
MAX
Jun 16, 2023K231199Solar Lumbar Interbody Fusion System
Degen Medical
MAX

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.