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Choice Spine LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30058194743005819474Choice Spine LLC1N2026-01-01400 Erin Dr Knoxville TN US 37919

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
671111821009733K9942885.0MM SPINAL SCREWSMNH2000-04-10
671111386092620K993926OMNIAXIAL CONNECTORMNH1999-12-17
671111812432309K983353SCS SPINAL SYSTEMKWP1998-12-18
671111991250748K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemOVE2023-09-14
671111485688293K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemMAX2022-09-13
671111827056810K220024ChoiceSpine Navigation SystemOLO2022-07-06
671111164761243K211449Triton™ Sacroiliac Joint Fixation SystemOUR2021-08-31
671111369872923K203561ChoiceSpine Navigation SystemOLO2021-01-04
671111257073798K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemOVE2021-05-10
671111911263197K201643ChoiceSpine Tiger Shark Cervical Spacer SystemODP2020-12-22
671111425612408K191367Harrier-SA Lumbar Interbody SystemMAX2019-07-05
671111451280342K190227Boomerang™ Anterior Cervical Plate SystemKWQ2019-05-01
671111740977410K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemMQP2019-02-22
671111042529668K183397ChoiceSpine Stealth Cervical Spacer SystemODP2019-03-06
671111423035561K183214Raven Lumbar Plate SystemKWQ2019-01-03
671111658288297K182721Choice Spine Navigation SystemOLO2019-01-08
671111674049335K182074Mineral Collagen Composite Bioactive MoldableMQV2019-03-21
671111205432689K180519HARRIER-SA™ Lumbar Interbody SystemOVD2018-05-16
671111703539001K173215Choice Spine Laminoplasty™ Fixation SystemNQW2018-01-19
671112032069579K172816TiGer Shark™ SystemMAX2018-01-26
671111162646338K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemMQP2017-09-15
671111853333586K171489Acapella Cervical Spacer SystemOVE2017-10-23
671111389750005K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsNKB2017-08-03
671111357754611K170953Tomcat Cervical Spinal SystemOVE2017-04-21
671111058291396K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsNKB2017-04-26
671111229393176K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemNKB2017-06-08
671111825515421K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)MAX2016-11-23
671111853724511K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsNKB2016-06-03
671111371735393K160697Gibralt® Spine System and Gibralt® Occipital Spine SystemNKG2016-06-28
671111282185218K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion SystemMAX2016-05-19
671111818979623K152515TOMCAT Cervical Spinal SystemOVE2015-12-18
671111003878406K150152The Octane Straight Intervertebral Fusion Device, Ti CoatedMAX2015-05-11
671111175840161K150130Ascendant TM Cervical Spacer SystemODP2015-05-28
671111309587444K143576Exactech AmbassadorKWQ2015-02-27
671111066717051K141129EXACTECH CERVICAL SPACER SYSTEMODP2014-08-15
671111468252529K140645GIBRALT ROD-TO-ROD CROSS CONNECTORSKWP2014-04-11
671111532909008K140142CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON)MAX2014-07-16
671111982980764K133214BLACKBIRD SPINAL SYSTEMKWP2014-03-07
671111474316264K132582EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEMOVE2014-02-12
671111139739717K132049THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMSNKB2014-08-15
671111566583346K130434OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTICMAX2013-05-01
671111670232581K123997TRANS1LATERAL INTERBODY FUSION SYSTEMMAX2013-04-01
671111676274842K123607OCTANE ELEVATE SPINAL IMPLANT SYSTEMMAX2014-04-25
671111356043924K121877GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATESKWP2013-02-12
671112047637259K121850Typhoon(TM) Facet Screw Fixation SystemMRW2012-09-20
671111186463304K120991TRANS1 INTERBODY FUSION SYSTEMMAX2012-08-23
671111851936596K120570CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEMMQP2012-04-05
671111864553798K112097GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5MRW2011-11-21
671111449598060K110197EXACTECH GIBRALT SPINAL SYSTEMMNI2011-07-15
671111311816699K102870EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEMMNH2011-01-21
671111617441765K102204CHOICE SPINE STARFIRE PEDICLE SCREW SYSTEMNKB2010-11-15
671111042753013K100210TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, TMAX2010-08-26
671111147040107K091926CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEMKWQ2009-12-22
671111608751870K091531CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACERODP2009-11-02
671111476199271K082270OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEMMAX2008-09-16
671111658219402K073669ORIA NATURA SPACERMAX2008-02-13
671111014295464K073245EXTENDED VERTIFLEX SPINAL SCREW SYSTEMNKB2008-02-15
671111971102453K070218VERTIFLEX OCTANE PEEK VERTEBRAL BODY REPLACEMENT (PEEK VBR)MQP2007-04-06
671111751529279K062670VERTIFLEX SPINAL SCREW SYSTEMMNH2007-01-12
671111467381657K061482ALTES BUTTRESS PLATING SYSTEMKWQ2006-07-26
671111224636245K040346MODIFICATION TO ORIA TOP CLIP SYSTEMMNI2004-03-12
671111324914044K031471ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01KWP2003-10-10
671111157421344K031452ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03KWP2003-06-18
671111017964063K030958ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORSMNI2003-11-20
671111357466094K030253ORIA SPINAL CLIP SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06KWP2003-02-21
671112054164117K030252ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07)KWP2003-02-21
671111325818715K023994ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJMNH2003-02-05
671111680035831K023884MODIFICATION ORIA SPINAL SYSTEMKWP2003-08-20
671111704389149K023378ORIA CLARISMNH2003-06-27
671112033404534K023377ORIA CERVICAL PLATESKWQ2003-03-04
671111817302268K021919SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALOKWP2002-07-03
671111289693490K021679ORIA SPINAL CLIP SYSTEMKWP2002-11-19
671111173375015K021379SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06MNI2002-05-31
671111766770100K011807SCS CLARIS SPINAL SCREWS, TYPES V,G,EMNI2001-08-07
671112005551513K010369CLARIS PLATE SYSTEMMNH2001-05-08
671111490786189K003823SCS DT-02 TRANSVERSE CONNECTORKWP2001-07-11
671111330649576
671111464788308
671111468308707

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX142022-09-13
KWP122014-04-11
NKB72017-08-03
MNH72011-01-21
OVE62023-09-14
KWQ62019-05-01
ODP52020-12-22
MNI52011-07-15
MQP42019-02-22
OLO32022-07-06
MRW22012-09-20
OUR12021-08-31
MQV12019-03-21
OVD12018-05-16
NQW12018-01-19
NKG12016-06-28

PMN#

GUDID#

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