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 28, 2014K141443INFRONT LUMBAR INTERBODY FUSION SYSTEM
Infront Medical, LLC
MAX
Jul 25, 2014K140770MLX - MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM
Nu Vasive, Incorporated
MAX
Jul 24, 2014K132907PLIF LITE AND TLIF LITE
Sintea Plustek
MAX
Jul 16, 2014K141217ACCULIF TL AND PL CAGE
Stryker Corporation
MAX
Jul 16, 2014K140142CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON)
Choicespine, LP
MAX
Jul 15, 2014K133813FLXFIT INTERVERTEBRAL BODY FUSION DEVICE
Expanding Orthopedics, Inc.
MAX
Jul 15, 2014K133053MILESTONE SPINAL SYSTEM
Weigao Orthopaedic Device Co., Ltd., CN
MAX
Jul 2, 2014K140162AP EXPANDABLE XLIF SYSTEM
Nuvasive, Inc.
MAX
Jul 2, 2014K140055ENDOSKELETON(R) TL INTERBODY FUSION DEVICE
Titan Spine, LLC
MAX
Jul 1, 2014K140411ALTERA SPACER
Globus Medical, Inc.
MAX
Jun 26, 2014K140659COROENT THORACOLUMBAR IMPLANTS
Nu Vasive, Incorporated
MAX
Jun 13, 2014K140759BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE INLINE LUMBAR, COUGAR SYSTEM, COUGAR LS LATERAL
Medos International SARL
MAX
Jun 5, 2014K140564BN LUMBAR CAGE SYSTEM
Medyssey USA, Inc.
MAX
May 29, 2014K132852PEEK CAGE FOR THE VERTEBRAL SPINE
Neoortho Produtos Ortopedicos S/A
MAX
May 27, 2014K140709SKYHAWK INTERBODY FUSION SYSTEM
Orthofix, Inc.
MAX
May 1, 2014K133514XCAGE INTERBODY FUSION SYSTEM
Ouroboros Medical
MAX
May 1, 2014K133418INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM
Seaspine, Inc.
MAX
Apr 25, 2014K123607OCTANE ELEVATE SPINAL IMPLANT SYSTEM
Exactech, Inc.
MAX
Apr 21, 2014K140303ALAMO T
Alliance Partners, LLC
MAX
Apr 18, 2014K140474JULIET OL
Spineart, CH
MAX
Apr 18, 2014K131612ANYPLUS; ALIF PEEK CAGES, PLIF PEEK CAGES, T-PLIF PEEK CAGES, TLIF PEEK CAGES
GS Medical Co., Ltd.
MAX
Apr 15, 2014K132738COGENT MED-LIF
Cogent Spine, LLC
MAX
Apr 11, 2014K133340SPINEWORKS ANTERIOR LUMBAR DEVICE
Spineworks, LLC
MAX
Apr 7, 2014K140007ABACUS TM SPACER SYSTEM
Spine Wave, Inc.
MAX
Apr 3, 2014K133614ALEUTIAN IBF SYSTEM
K2m, Inc.
MAX
Mar 31, 2014K133721INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE AND THE INFILL 60
Pinnacle Spine Group, LLC
MAX
Mar 27, 2014K133455CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC
Pioneer Surgical Technology, Inc.
MAX
Mar 20, 2014K134038CAMBER SPINE DIAGON OBLIQUE CAGE
Camber Spine
MAX
Mar 14, 2014K133893STERISPINE LC CAGE
Safe Orthopaedics, FR
MAX
Mar 13, 2014K133205CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
MAX
Mar 6, 2014K133459ELITE IBF
Innova Spinal Technologies, LLC
MAX
Feb 10, 2014K133583OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070
Interventional Spine, Inc.
MAX
Feb 3, 2014K133557JULIET LL LATERAL LUMBAR CAGE
Spineart, CH
MAX
Feb 3, 2014K131292DEROYAL SPINE SPACER SYSTEM
Deroyal Industries, Inc.
MAX
Jan 31, 2014K133967INTERBODY CAGE SYSTEM
Aurora Spine
MAX
Jan 30, 2014K133192MECTALIF TIPEEK
Medacta International
MAX
Jan 30, 2014K133184ARDIS INTERBODY SYSTEM
Zimmer Spine, Inc.
MAX
Jan 22, 2014K132421AESCULAP PEEK XP SPINAL IMPLANT SYSTEM
Aesculap Implant Systems, Inc.
MAX
Jan 9, 2014K133371RAMPART-L
Spineology, Inc.
MAX
Jan 3, 2014K133645PERIMETER C SPINAL SYSTEM, CAPSTONE SPINAL SYSTEM, CAPSTONE L SPINAL SYSTEM, PERIMETER SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
MAX
Dec 24, 2013K132601COROENT STERILE IMPLANTS SYSTEM
Nu Vasive, Incorporated
MAX
Dec 20, 2013K133650CAPSTONE SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
MAX
Dec 20, 2013K132790INFIX ANTERIOR LUMBAR SYSTEM
Zimmer Spine, Inc.
MAX
Dec 13, 2013K130913GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM
Genesys Spine
MAX
Dec 11, 2013K132897CLYDESDALE SPINAL SYSTEM
Medtronic Sofamor Danek, Inc.
MAX
Dec 9, 2013K133126K7 LUMBAR SPACERS
K7, LLC
MAX
Nov 22, 2013K133216CRESCENT SPINAL SYSTEM
Medtronic Sofamor Danek, Inc.
MAX
Nov 1, 2013K131669PERIMETER INTERBODY FUSION DEVICE
Medtronic Sofamor Danek USA, Inc.
MAX
Oct 29, 2013K130274BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM
Elite Surgical Supplies (Pty), Ltd., ZA
MAX
Oct 23, 2013K131350CALIX LUMBAR SPINAL IMPLANT SYSTEM
X-Spine Systems, Inc.
MAX

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