510(k) Report

Devices descending from K020152

1,684 later devices reach Synthes Vertebral Spacer TI through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+9K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+9K161028K2M Growing Spine SystemK2m, Inc.20163—
+9K161369EVEREST Spinal SystemK2m, Incorporated20169—
+9K160631Keos Lumbar IBFDKeos20161—
+9K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+9K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.201612—
+9K153436LATERAL Spine Truss System4Web, Inc.20165—
+9K153629ArcadiusXP C Spinal SystemAesculap Implant Systems, Inc.20167—
+9K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A.201613—
+9K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+9K160418PERIMETER Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.20165—
+9K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+9K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+9K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+9K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+9K151216Everest Spinal SystemK2m, Inc.201511—
+9K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+9K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+9K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+9K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+9K150954Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC20156—
+9K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+9K143616AccuLIF TL and PL CageStryker Corporation20154694
+9K141187Impix Alif S/aMedicrea International SA201501
+9K141896Coroent SystemNu Vasive, Incorporated2014480—
+9K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+9K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+9K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+9K133402K2M Modular HooksK2m, Inc.20140—
+9K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+9K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+9K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+9K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+9K132700Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek, Inc.2013170—
+9K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+9K130461Stalif XCentinel Spine, Inc.201313—
+9K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG20130—
+9K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+9K112700Frontier Sadl Interbody Fusion DeviceFrontier Medical Devices, Inc.20121—
+9K120869Anchor-L Lumbar CageStryker Spine2012638—
+9K122085Stingray Cervical CageOmni Surgical, LP Dba Spine36020120—
+9K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+9K122591Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.201214—
+9K121892Phantom Plus Ceramic Cage SystemAmedica Corp.20127—
+9K120991TRANS1 Interbody Fusion SystemTrans1 Incorporated2012172—
+9K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+9K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+9K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+9K113642Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA2012292—
+9K112405Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc.2011296—
+9K110063Sovereign Spinal SystemMedtronic Sofamor Danek, Inc.2011718—
+9K111525Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2011355—
+9K103655Octane-C Interbody Fusion Device SystemExactech, Inc.2011481
+9K103369Vault Alif SystemSpinal USA201110—
+9K093093Small Plateau Spacer SystemLife Spine2010393—
+9K101301Stalif MidlineCentinel Spine2010474—
+9K083475Lucent MagnumSpinal Elements, Inc.2009834—
+9K081711Lucent Magnum+Spinal Elements, Inc.20080—
+10K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+10K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+10K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+10K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+10K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+10K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+10K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+10K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+10K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+10K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+10K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+10K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+10K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+10K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+10K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+10K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+10K201793EDEN Peek CageJmt Co., Ltd.20210—
+10K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+10K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+10K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+10K200592GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd.20206—
+10K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+10K193174Keos Lumbar IBFDKeos20190—
+10K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+10K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+10K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+10K182721Choice Spine Navigation SystemChoicespine, LP20192—
+10K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+10K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+10K181188EVEREST Spinal SystemK2m, Inc.20186—
+10K180437Hexanium® TLIFSpinevision, S.A.S.20182—
+10K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+10K171321K2M Navigation InstrumentsK2m201711
+10K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+10K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+10K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+10K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+10K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+10K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—