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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
Oct 1, 2010K100042DIFUSION TECHNOLOGIES XIPHOS INTERBODY FUSION SYSTEM
Difusion Technologies
MAX
Sep 24, 2010K101301STALIF MIDLINE
Centinel Spine
MAX
Sep 23, 2010K100037ADVANCED VERTEBRAL SOLUTIONS EXPRESS BFD
Advanced Vertebral Solutions, LLC
MAX
Aug 26, 2010K100210TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T
Trans1 Incorporated
MAX
Aug 12, 2010K101051AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXX
Stryker Spine
MAX
Aug 11, 2010K100865AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX
Stryker Spine
MAX
Aug 10, 2010K100743ATLAS SPINE PIVOTING SYSTEM
Atlas Spine, Inc.
MAX
Aug 5, 2010K100820WENZEL SPINE VARILIFT INTERBODY FUSION SYSTEM
Wenzel Spine
MAX
Jul 22, 2010K100544IMPIX LUMBAR INTERBODY DEVICE
Medicrea Technologies
MAX
Jul 16, 2010K101720JULIET OL
Spineart, CH
MAX
Jul 1, 2010K101085SPINESMITH CYNCH SPINAL SYSTEM
Spine Smith Partners L.P.
MAX
Jun 30, 2010K092815S-LIF INTERVERTEBRAL BODY FUSION DEVICE
Spinefrontier, Inc.
MAX
Jun 2, 2010K100175CLYDESDALE SPINAL SYSTEM
Medtronic Sofamor Danek
MAX
May 19, 2010K083798IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF
Medicrea Technologies
MAX
May 13, 2010K100089SYNTHES T-PAL SPACER
Synthes Spine
MAX
Apr 28, 2010K092901EPICAGE INTERBODY FUSION DEVICE
R Tree Innovations
MAX
Apr 26, 2010K094025CRESCENT SPINAL SYSTEM
Medtronic Sofamor Danek
MAX
Mar 18, 2010K093669SEC IBF CAGE
Innvotec Surgical, Inc.
MAX
Mar 11, 2010K093864AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX
Stryker Corp.
MAX
Feb 25, 2010K093015BINDER INTERVERTEBRAL BODY FUSION DEVICE
Binder Biomedical, Inc.
MAX
Feb 4, 2010K092574ESL SPINAL SYSTEM
Ebi, L.P.
MAX
Feb 2, 2010K092774ATLAS INTERVERTEBRAL BODY CAGE
Spinal Edge, LLC
MAX
Jan 28, 2010K091278VALEO SPACER SYSTEM
Amedica Corp.
MAX
Jan 6, 2010K0921624CIS PEEK, PLIF AND TLIF CAGE SYSTEM
Solco Biomedical Co., Ltd.
MAX
Dec 23, 2009K093704AVS PL PEEK SPACERS
Stryker Corp.
MAX
Dec 23, 2009K093675INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076
Vertebral Technologies, Inc.
MAX
Dec 23, 2009K093242PATRIOT TRANSCONTINENTAL LLIF SPACER
Globus Medical, Inc.
MAX
Dec 1, 2009K092017PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD)
Captiva Spine, Inc.
MAX
Oct 19, 2009K083626DISTRACTABLE WAVE CAGE
Advanced Medical Technology, Inc.
MAX
Sep 29, 2009K090353PERIMETER INTERBODY FUSION DEVICE
Medtronic Sofamor Danek
MAX
Sep 25, 2009K092193SPINAL USA INTERBODY CAGES
Spinal USA
MAX
Sep 18, 2009K091122DIANA FUSION CAGE
Signus Medical
MAX
Sep 14, 2009K091638DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031
Spinefrontier, Inc.
MAX
Aug 14, 2009K090048ASFORA BULLET CAGE SYSTEM
Medical Designs, LLC
MAX
Aug 7, 2009K091381IBEX SPINAL SYSTEM
Ebi, L.P.
MAX
Jul 30, 2009K091988MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE , MODEL 9076
Vertebral Technologies, Inc.
MAX
Jul 15, 2009K090707TALOS INTERVERTEBRAL BODY FUSION DEVICE
Meditech Advisors, LLC
MAX
Jun 25, 2009K090507MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM
Ldr Spine USA
MAX
Jun 1, 2009K090566PATHWAY AVID
Custom Spine, Inc.
MAX
May 22, 2009K081917DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS
Depuy Spine, Inc.
MAX
May 19, 2009K090899DEPUY SPINE LATERAL SYSTEM
Depuy Spine, Inc.
MAX
May 19, 2009K090425GUIDED LATERAL INTERBODY FUSION (GLIF) SYSTEM
Alphatec Spine, Inc.
MAX
Apr 24, 2009K090816STRYKER SPINE AVS PL PEEK SPACERS
Stryker Corp.
MAX
Apr 22, 2009K090782NOVEL ALIF SPINAL SPACER SYSTEM
Alphatec Spine, Inc.
MAX
Apr 22, 2009K090166AVS ANTERIOR LARGE PEEK SPACERS
Stryker Corp.
MAX
Apr 21, 2009K082698ALEUTIAN IBF SYSTEM
K2m, Inc.
MAX
Apr 20, 2009K083815LANX FUSION SYSTEM
Lanx, Inc.
MAX
Apr 15, 2009K083714ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD)
Titan Spine, LLC
MAX
Apr 9, 2009K090064EMINENT SPINE INTERBODY FUSION SYSTEM
Eminent Spine
MAX
Apr 1, 2009K090376SPINESMITH CYNCH SPINAL SYSTEM
Spine Smith Partners L.P.
MAX

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