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)
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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
Jun 13, 2019K191005ProLift® Expandable System
Life Spine, Inc.
MAX
May 23, 2019K183560Luna 3D GEN2 Interbody Fusion System
Benvenue Medical, Inc.
MAX
May 8, 2019K190092UNiD Patient specific 3D printed TLIF cage
Medicrea International SA, FR
MAX
May 6, 2019K190165Capstone Control™ Spinal System
Medtronic Sofamor Danek USA, Inc.
MAX
May 3, 2019K182877HALF DOME Posterior Lumbar Interbody System
Astura Medical, LLC
MAX
Apr 18, 2019K190364CancelleX Porous Titanium Lumbar Interbody Device
Xenco Medical, LLC
MAX
Apr 3, 2019K183184FlareHawk Interbody Fusion System
Integrity Implants, Inc.
MAX
Apr 3, 2019K182349CONCORDE LIFT
Medos International SARL, CH
MAX
Mar 13, 2019K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION™ P
MiRus, LLC
MAX
Mar 8, 2019K183092Kuros TLIF Cage
Kuros Biosciences B.V, NL
MAX
Mar 7, 2019K190055Duo Lumbar Interbody Fusion Device
Spineology, Inc.
MAX
Mar 7, 2019K173518Spectrum Spine Expandable Cages (SSEC)
Spectrum Spine, LLC
MAX
Mar 4, 2019K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices
Spineex, Inc.
MAX
Mar 1, 2019K183705IdentiTi Porous Ti Interbody System
Alphatec Spine, Inc.
MAX
Mar 1, 2019K183259Idys™ TLIF TiVac
Clariance, Sas, FR
MAX
Feb 22, 2019K182406Altus Spine Interbody Fusion System
Altus Partners, LLC
MAX
Feb 15, 2019K183049Reliance Lumbar IBF System
Reliance Medical Systems, LLC
MAX
Feb 6, 2019K183659Omnia Medical Rotary PLIF System
Omnia Medical, LLC
MAX
Feb 4, 2019K183447EIT Cellular Titanium Lumbar Cage - T/PLIF
Eit Emerging Implant Technologies GmbH, DE
MAX
Jan 29, 2019K181048Neo Cage System TM
Neo Medical SA, CH
MAX
Jan 28, 2019K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System
Wenzel Spine, Inc.
MAX
Jan 25, 2019K180230NEST Interbody System
Paonan Biotech Co., Ltd., TW
MAX
Jan 11, 2019K180228II-Type Intervertebral Spacer
Paonan Biotech Co., Ltd., TW
MAX
Jan 7, 2019K182210TiWAVE-L Porous Titanium Lumbar Cage
Kalitec Medical, LLC
MAX
Jan 7, 2019K182114FlareHawk Interbody Fusion System
Integrity Implants, Inc.
MAX
Dec 20, 2018K181589Curiteva Lumbar Interbody Fusion System
Curiteva, LLC
MAX
Dec 19, 2018K183239CoreLink F3D™ Lateral System
Corelink, LLC
MAX
Dec 13, 2018K181899ROCCIA® PLIF
Silony Medical GmbH, DE
MAX
Dec 11, 2018K181625Life Spine Resolute™ Threaded Cage System
Life Spine, Inc.
MAX
Dec 10, 2018K182584Lucent® XP
Spinal Elements, Inc.
MAX
Dec 6, 2018K181357PATRIOT® Lumbar Spacers, SUSTAIN® Spacers
Globus Medical, Inc.
MAX
Dec 6, 2018K181231DePuy Synthes T-PAL Spacer System
Depuy Synthes Spine
MAX
Dec 4, 2018K181970MectaLIF Posterior Extension
Medacta International S.A., CH
MAX
Nov 27, 2018K182746ATEC ALIF and LLIF Spacer System
Alphatec Spine, Inc.
MAX
Nov 26, 2018K182470Plateau Spacer System
Life Spine
MAX
Nov 14, 2018K181963ostaPek Interbody Fusion Cages
Coligne AG, CH
MAX
Nov 14, 2018K181829Velofix TLIF Cage
U&I Corporation, KR
MAX
Nov 2, 2018K181837Spinal Elements Ti-Bond coated devices
Spinal Elements, Inc.
MAX
Oct 24, 2018K182322Duo Lumbar Interbody Fusion Device
Spineology, Inc.
MAX
Oct 12, 2018K181644EIT Cellular Titanium® Lumbar Cage LLIF
Eit Emerging Implant Technologies GmbH, DE
MAX
Oct 5, 2018K181860NuVasive Cohere Thoracolumbar Interbody System
Nu Vasive, Incorporated
MAX
Oct 5, 2018K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices
Spineex, Inc.
MAX
Sep 27, 2018K181397DualX
Innovasive, Inc.
MAX
Sep 26, 2018K181591Fixated Asfora BULLET CAGE® (FABC)
Medical Designs, LLC
MAX
Sep 21, 2018K181702Tranquil-L Interbody System
Nexus Spine, LLC
MAX
Sep 18, 2018K181337Sypher Spacer System
Biogennix, LLC
MAX
Sep 11, 2018K181655Renovis S180 Lateral Lumbar Interbody Fusion System
Renovis Surgical Technologies
MAX
Sep 11, 2018K181380LnK Lumbar Interbody Fusion Cage System
L&K BIOMED Co., Ltd., KR
MAX
Aug 27, 2018K181483Tranquil Interbody System
Nexus Spine, LLC
MAX
Aug 24, 2018K180373CancelleX Porous Titanium Lumbar Interbody Device
Xenco Medical, LLC
MAX

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