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
Aug 15, 2018K181347Aries® Lumbar Interbodies
Osseus Fusion Systems, LLC
MAX
Aug 14, 2018K181792Duo™ Lumbar Interbody Fusion Device
Spineology, Inc.
MAX
Aug 13, 2018K180990TirboLOX-L Lumbar IBFD
Captiva Spine, Inc.
MAX
Aug 3, 2018K180777K2M Expandable Interbody System
K2m, Inc.
MAX
Jul 27, 2018K180556Corelink Foundation 3D Anterior Lumbar System
Corelink, LLC
MAX
Jul 27, 2018K180076Ti 3Z Interbody System
Zavation Medical Products, LLC
MAX
Jul 25, 2018K181453ATEC ALIF Spacer System
Alphatec Spine, Inc.
MAX
Jul 25, 2018K173947Lumbar Interbody Fusion System (OLLIF)
Advanced Research Medical, LLC
MAX
Jul 18, 2018K181079SeaSpine Regatta Lateral System
SeaSpine Orthopedics Corporation
MAX
Jul 18, 2018K181014Tritanium PL Cage
Stryker Spine
MAX
Jul 17, 2018K181030Rubicon Lumbar Interbody Fusion System
Rubicon Spine, LLC
MAX
Jul 11, 2018K180963ROCCIA ALIF, ROCCIA TLIF
Silony Medical GmbH, DE
MAX
Jul 10, 2018K181246Zavation IBF System
Zavation Medical Products, LLC
MAX
Jul 2, 2018K173864Peekplus® Interbody Fusion Device
Vallum Corporation
MAX
Jun 28, 2018K181203Juliet Ti
Spineart, CH
MAX
Jun 25, 2018K180724SPIRA Open Matrix LLIF
Camber Spine Technologies, LLC
MAX
Jun 8, 2018K173189Lumfuse TP
Precifit Medical, Ltd.
MAX
May 15, 2018K180687Reliance Lumber IBF System
Reliance Medical Systems
MAX
May 8, 2018K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and
Centinel Spine, Inc.
MAX
May 4, 2018K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody System
Cutting Edge Spine, LLC
MAX
May 4, 2018K180437Hexanium® TLIF
Spinevision, S.A.S., FR
MAX
May 4, 2018K173892NuVasive® XLX Interbody System
Nu Vasive, Incorporated
MAX
May 3, 2018K180071STYLO Interbody Fusion Device
Legend Spine Technologies
MAX
Apr 27, 2018K171151ACRON™ TLIF System
Spinemed Ges.M.B.H, AT
MAX
Apr 25, 2018K173782UNiD Patient Specific 3D printed cage
Medicrea International SA, FR
MAX
Apr 18, 2018K172947HALF DOME Posterior Lumbar Interbody System
Astura Medical
MAX
Apr 17, 2018K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System
Innovasis, Inc.
MAX
Mar 22, 2018K180431Cortina [MAX] Lumbar Cage System
Neurostructures, Inc.
MAX
Feb 12, 2018K171495Zyston Strut Open Titanium Spacer System
Zimmer Biomet Spine, Inc.
MAX
Feb 8, 2018K173537CONCORDE LIFT™
Medos International SARL, CH
MAX
Feb 8, 2018K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP Expandable XLIF System
Nu Vasive, Incorporated
MAX
Feb 2, 2018K172105The Plateau-LO Spacer System
Life Spine, Inc.
MAX
Feb 1, 2018K172828Double Medical Cage System
Double Medical Technology, Inc., CN
MAX
Jan 26, 2018K172816TiGer Shark™ System
Choicespine, LP
MAX
Jan 22, 2018K171312FortiCore®
Nanovis, LLC
MAX
Jan 19, 2018K173283Reliance Lumbar IBF System
Reliance Medical Systems, LLC
MAX
Jan 19, 2018K172696FORZA® XP Expandable Spacer System
Orthofix, Inc.
MAX
Jan 18, 2018K173476Tritanium® TL Curved Posterior Lumbar Cage
Stryker
MAX
Jan 3, 2018K173702Juliet Ti LL
Spineart, CH
MAX
Dec 21, 2017K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, C
Globus Medical, Inc.
MAX
Dec 21, 2017K171434ROCCIA® MultiLIF
Silony Medical GmbH, DE
MAX
Dec 20, 2017K173182ProLift® Expandable System
Life Spine, Inc.
MAX
Dec 15, 2017K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellula
Eit Emerging Implant Technologies GmbH, DE
MAX
Dec 15, 2017K172465Idys™ TLIF 3DTi Cages
Clariance, Sas, FR
MAX
Dec 14, 2017K172349InFill® Interbody Fusion Device
Pinnacle Spine Group, LLC
MAX
Dec 14, 2017K172009Cascadia Interbody System
K2m, Inc.
MAX
Dec 14, 2017K170389TAURUS PEEK Cage System
Medyssey USA, Inc.
MAX
Dec 8, 2017K172756Varian cage
Medyssey USA, Inc.
MAX
Dec 6, 2017K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System
Nu Vasive, Incorporated
MAX
Dec 4, 2017K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Ho
SeaSpine Orthopedics Corporation
MAX

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