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MAX

895 FDA 510(k) clearances · Product code

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RecordFirmDateBuilder
ADVANCED VERTEBRAL SOLUTIONS EXPRESS BFD (K100037)Advanced Vertebral Solutions, LLC2010-09-23+ Add
TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T (K100210)Trans1 Incorporated2010-08-26+ Add
AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXX (K101051)Stryker Spine2010-08-12+ Add
AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX (K100865)Stryker Spine2010-08-11+ Add
ATLAS SPINE PIVOTING SYSTEM (K100743)Atlas Spine, Inc.2010-08-10+ Add
WENZEL SPINE VARILIFT INTERBODY FUSION SYSTEM (K100820)Wenzel Spine2010-08-05+ Add
IMPIX LUMBAR INTERBODY DEVICE (K100544)Medicrea Technologies2010-07-22+ Add
JULIET OL (K101720)Spineart2010-07-16+ Add
SPINESMITH CYNCH SPINAL SYSTEM (K101085)Spine Smith Partners L.P.2010-07-01+ Add
S-LIF INTERVERTEBRAL BODY FUSION DEVICE (K092815)Spinefrontier, Inc.2010-06-30+ Add
CLYDESDALE SPINAL SYSTEM (K100175)Medtronic Sofamor Danek2010-06-02+ Add
IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF (K083798)Medicrea Technologies2010-05-19+ Add
SYNTHES T-PAL SPACER (K100089)Synthes Spine2010-05-13+ Add
EPICAGE INTERBODY FUSION DEVICE (K092901)R Tree Innovations2010-04-28+ Add
CRESCENT SPINAL SYSTEM (K094025)Medtronic Sofamor Danek2010-04-26+ Add
SEC IBF CAGE (K093669)Innvotec Surgical, Inc.2010-03-18+ Add
AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX (K093864)Stryker Corp.2010-03-11+ Add
BINDER INTERVERTEBRAL BODY FUSION DEVICE (K093015)Binder Biomedical, Inc.2010-02-25+ Add
ESL SPINAL SYSTEM (K092574)Ebi, L.P.2010-02-04+ Add
ATLAS INTERVERTEBRAL BODY CAGE (K092774)Spinal Edge, LLC2010-02-02+ Add
VALEO SPACER SYSTEM (K091278)Amedica Corp.2010-01-28+ Add
4CIS PEEK, PLIF AND TLIF CAGE SYSTEM (K092162)Solco Biomedical Co., Ltd.2010-01-06+ Add
AVS PL PEEK SPACERS (K093704)Stryker Corp.2009-12-23+ Add
INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076 (K093675)Vertebral Technologies, Inc.2009-12-23+ Add
PATRIOT TRANSCONTINENTAL LLIF SPACER (K093242)Globus Medical, Inc.2009-12-23+ Add
PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD) (K092017)Captiva Spine, Inc.2009-12-01+ Add
DISTRACTABLE WAVE CAGE (K083626)Advanced Medical Technology, Inc.2009-10-19+ Add
PERIMETER INTERBODY FUSION DEVICE (K090353)Medtronic Sofamor Danek2009-09-29+ Add
SPINAL USA INTERBODY CAGES (K092193)Spinal USA2009-09-25+ Add
DIANA FUSION CAGE (K091122)Signus Medical2009-09-18+ Add
DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031 (K091638)Spinefrontier, Inc.2009-09-14+ Add
ASFORA BULLET CAGE SYSTEM (K090048)Medical Designs, LLC2009-08-14+ Add
IBEX SPINAL SYSTEM (K091381)Ebi, L.P.2009-08-07+ Add
MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE , MODEL 9076 (K091988)Vertebral Technologies, Inc.2009-07-30+ Add
TALOS INTERVERTEBRAL BODY FUSION DEVICE (K090707)Meditech Advisors, LLC2009-07-15+ Add
MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM (K090507)Ldr Spine USA2009-06-25+ Add
PATHWAY AVID (K090566)Custom Spine, Inc.2009-06-01+ Add
DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS (K081917)Depuy Spine, Inc.2009-05-22+ Add
GUIDED LATERAL INTERBODY FUSION (GLIF) SYSTEM (K090425)Alphatec Spine, Inc.2009-05-19+ Add
DEPUY SPINE LATERAL SYSTEM (K090899)Depuy Spine, Inc.2009-05-19+ Add
STRYKER SPINE AVS PL PEEK SPACERS (K090816)Stryker Corp.2009-04-24+ Add
NOVEL ALIF SPINAL SPACER SYSTEM (K090782)Alphatec Spine, Inc.2009-04-22+ Add
AVS ANTERIOR LARGE PEEK SPACERS (K090166)Stryker Corp.2009-04-22+ Add
ALEUTIAN IBF SYSTEM (K082698)K2m, Inc.2009-04-21+ Add
LANX FUSION SYSTEM (K083815)Lanx, Inc.2009-04-20+ Add
ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD) (K083714)Titan Spine, LLC2009-04-15+ Add
EMINENT SPINE INTERBODY FUSION SYSTEM (K090064)Eminent Spine2009-04-09+ Add
SPINESMITH CYNCH SPINAL SYSTEM (K090376)Spine Smith Partners L.P.2009-04-01+ Add
AVS TL PEEK SPACERS (K083661)Stryker Corp.2009-02-27+ Add
DYNAMIK INTERVERTEBRAL BODY FUSION DEVICE (K081888)Spineart2009-02-06+ Add
LDR SPINE ROI INTERBODY FUSION SYSTEM (K082262)Ldr Spine USA2009-02-02+ Add
EXPANDABLE PEEK-OPTIMA IMPLANT (K082406)Ebi, L.P.2009-01-14+ Add
THEKEN SPINE VU EPOD AND VU LPOD SYSTEM (K082712)Theken Spine, LLC2009-01-02+ Add
CLYDESDALE SPINAL SYSTEM (K083026)Medtronic Sofamor Danek2008-12-29+ Add
DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE (K081673)Ionics Medical Corp.2008-11-14+ Add
DEPUY SPINE LATERAL CAGE SYSTEM (K082128)Depuy Spine2008-11-14+ Add
HOLLYWOOD, PACIFICA, REDONDO, VENTURA (K082310)Seaspine, Inc.2008-11-10+ Add
LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE (K082774)Lanx, LLC2008-10-21+ Add
INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES (K082260)Calvary Spine, LLC2008-10-17+ Add
SPINAL USA VBR SYSTEM (K081196)Spinal USA2008-10-16+ Add
MODIFICATION TO: CAPSTONE SPINAL SYSTEM (K082732)Medtronic Sofamor Danek USA, Inc.2008-10-16+ Add
OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM (K082270)Vertiflex, Inc.2008-09-16+ Add
MODIFICATION TO CAPSTONE SPINAL SYSTEM (K082342)Medtronic Sofamor Danek2008-09-12+ Add
BLACKSTONE PILLAR XL PEEK SPACERS (K082235)Blackstone Medical, Inc.2008-09-04+ Add
PEEK-OPTIMA ALIF SPACER (K081636)Biomet Spine2008-08-07+ Add
MODIFICATION TO LUCENT (K081968)Spinal Elements, Inc.2008-08-05+ Add
STRYKER SPINE AVS PL PEEK SPACERS (K082014)Stryker Corp.2008-07-28+ Add
BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM (K081177)Blackstone Medical, Inc.2008-07-23+ Add
L-VARLOCK (K080537)Kiscomedica S.A.2008-06-30+ Add
ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD) (K080615)Titan Spine, LLC2008-06-17+ Add
INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE (K080673)Vertebral Technologies, Inc.2008-06-10+ Add
SCIENT'X TRIBECA VBR (K080588)Scient'X USA, Inc.2008-05-30+ Add
PLATEAU SPACER SYSTEM (K080411)Life Spine2008-05-15+ Add
PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM (K073177)Pioneer Surgical Technology2008-05-13+ Add
SPINAL USA INTERBODY FUSION DEVICE (K080314)Spinal USA2008-05-13+ Add
SHELL CAGE, WAVE CAGE, LOOP CAGE (K080401)Advanced Medical Technologies AG2008-05-09+ Add
PATHWAY (K080281)Custom Spine, Inc.2008-05-01+ Add
AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE (K071983)Aesculap Implant Systems, Inc.2008-05-01+ Add
FOUNDATION CAGE (K073440)Corelink, LLC2008-04-24+ Add
CAPSTONE SPINAL SYSTEM (K073291)Medtronic Sofamor Danek USA, Inc.2008-04-24+ Add
TURBO PRIME IBD SYSTEM (K080058)Spineselect, LLC2008-04-16+ Add
INTREPID SPINAL SYSTEM (K080083)Medtronic Sofamor Danek2008-04-10+ Add
AVS PL PEEK SPACERS, MODELS 48351 AND 48353 (K080758)Stryker Corp.2008-03-27+ Add
AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX (K073470)Stryker Spine2008-03-06+ Add
ORIA NATURA SPACER (K073669)Choicespine, LP2008-02-13+ Add
ARDIS SPACER (K073202)Abbott Spine, Inc.2008-01-30+ Add
LANX INTERVERTEBRAL BODY FUSION DEVICE (K073144)Lanx, LLC2008-01-24+ Add
PATRIOT SPACERS (K072970)Globus Medical, Inc.2008-01-18+ Add
LUCENT MAGNUM (K073348)Spinal Elements, Inc.2007-12-26+ Add
ORACLE SPACER, OPAL SPACER (K072791)Synthes Spine2007-12-26+ Add
IMPIX SPACER (K072226)Medicrea Technologies2007-12-10+ Add
NUVASIVE COROENT SYSTEM (K071795)Nuvasive, Inc.2007-12-04+ Add
LUCENT (K071724)Spinal Elements, Inc.2007-11-09+ Add
SPINEFRONTIER DORADO VBR (K072289)Spinefrontier, Inc.2007-11-01+ Add
PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE (K072120)Innovative Spinal Technologies, Inc.2007-10-11+ Add
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