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
Apr 25, 2017K170511NeoFuse HA Enhanced PLIF/TLIF
Ht Medical, LLC
MAX
Apr 14, 2017K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System
Rti Surgical, Inc. Dba Rti Biologics
MAX
Apr 10, 2017K163386Keos Lumbar IBFD
Keos
MAX
Apr 6, 2017K163246Leva Anterior Expandable Spacer System
Spine Wave, Inc.
MAX
Apr 4, 2017K162206Zavation IBF
Zavation, LLC
MAX
Mar 31, 2017K170243LOSPA IS TLIF & DLIF Cages
Corentec Co., Ltd., KR
MAX
Mar 29, 2017K162693VertebraLINK Fusion Platform
Facetlink Dba Linkspine
MAX
Mar 16, 2017K163230NuVasive Modulus XLIF Interbody System
Nu Vasive, Incorporated
MAX
Mar 15, 2017K163364MOJAVE Expandable Interbody System
K2m
MAX
Mar 10, 2017K170512Altus Spine Titanium Interbody Fusion System
Altus Partners, LLC
MAX
Mar 8, 2017K163409Rampart(TM) T Lumbar Interbody Fusion Device
Spineology, Inc.
MAX
Feb 22, 2017K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEP
Globus Medical, Inc.
MAX
Feb 9, 2017K162918Atlas Spine Expandable Interbody System
Atlas Spine, Inc.
MAX
Jan 30, 2017K162879Elite Expandable Interbody Fusion Device
Spineology, Inc.
MAX
Jan 25, 2017K160976Altus Spine Interbody Fusion System
Altus Partners, LLC
MAX
Dec 29, 2016K163180Hubble II
Orbbo Surgical, LLC
MAX
Dec 22, 2016K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System
Orthofix, Inc.
MAX
Dec 12, 2016K162327COUGAR® LS Lateral Cage System and COUGAR® System
Medos International SARL, CH
MAX
Nov 23, 2016K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™),
Choicespine, LP
MAX
Nov 17, 2016K162431Luna 3D Interbody Fusion System
Benvenue Medical, Inc.
MAX
Nov 17, 2016K160959Xsert Lumbar Expandable Interbody System
X-Spine Systems, Inc.
MAX
Nov 16, 2016K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)
Evolution Spine, LLC
MAX
Nov 9, 2016K162262Tritanium® PL Cage
Stryker
MAX
Nov 8, 2016K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion System
Genesys Spine
MAX
Nov 8, 2016K160924Amendia Interbody Fusion Devices
Amendia, Inc.
MAX
Nov 1, 2016K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System
Synthes USA Products, LLC
MAX
Oct 28, 2016K162715SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMe
SeaSpine Orthopedics Corporation
MAX
Oct 18, 2016K160074Rampart D Lumbar Interbody Fusion Device
Spineology, Inc.
MAX
Oct 13, 2016K160076XCage™ Interbody Fusion System
Ouroboros Medical, Inc.
MAX
Sep 29, 2016K162426nva, nvp, and nvt
Nvision Biomedical Technologies, LLC
MAX
Sep 21, 2016K162264Cascadia Interbody System
K2m, Inc.
MAX
Sep 15, 2016K153665PROW FUSION-L
Nlt Spine, Ltd., IL
MAX
Sep 12, 2016K161888JULIET® LL Lateral Lumbar Cage
Spineart, CH
MAX
Sep 6, 2016K161485Nanovis Intervertebral Body Fusion System and Forticore(R)
Nanovis, LLC
MAX
Aug 25, 2016K161230NuVasive Lumbar Interbody Implants
Nu Vasive, Incorporated
MAX
Aug 24, 2016K160646XYcor® Expandable Spinal Spacer System
Alphatec Spine, Inc.
MAX
Aug 19, 2016K161405Valeo II Interbody Fusion Device System
Amedica Corp.
MAX
Aug 1, 2016K160856SpineView X-Pac Expandable Lumbar Cage System
Spine View, Inc.
MAX
Aug 1, 2016K160699VIRTU Lumbar Spacer System
Met 1 Technologies, LLC
MAX
Jul 21, 2016K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion System
Genesys Spine
MAX
Jul 21, 2016K160955Tritanium® PL Cage
Stryker
MAX
Jul 15, 2016K160631Keos Lumbar IBFD
Keos
MAX
Jul 15, 2016K153621Juliet® Ti
Spineart, CH
MAX
Jul 14, 2016K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion De
Spineology, Inc.
MAX
Jul 11, 2016K153786PROW FUSION-V
Nlt Spine, Ltd., IL
MAX
Jul 11, 2016K153105MLX™ - Medial Lateral Expandable Lumbar Interbody System
Nu Vasive, Incorporated
MAX
Jul 8, 2016K160715AccuLIF TL and PL Cage
Stryker Corporation
MAX
Jun 29, 2016K152501Spinal Jaxx Interbody Fusion Device
Neuropro Spinaljaxx, Inc.
MAX
Jun 28, 2016K160916CoRoent® Ti-C System
Nu Vasive, Incorporated
MAX
Jun 28, 2016K160874Nanovis Intervertebral Body Fusion System and FortiCore®
Nanovis, LLC
MAX

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