510(k) Report

Devices descending from K072253

1,250 later devices reach Synfix-LR Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+5K152651AccuLIF TL and PL CageStryker Corporation201530—
+5K143479Bluefin Interbody SystemTides Medical20152—
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K150481Cascadia Interbody SystemK2m, Inc.20154593
+5K142392Zavation Posterior LEIFZavation, LLC20150—
+5K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+5K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+5K142360Everest Spinal SystemK2m, Inc.201522—
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+5K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+5K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+5K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+5K133784Vista-S Device, Associated InstrumentationZimmer Trabecular Metal Technology201429—
+5K141147Range Spinal SystemK2m, Inc.20141—
+5K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+5K130853Idys (TM) CClariance20132—
+5K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+5K123913Latis SpacerGlobus Medical, Inc.201388—
+5K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+5K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+5K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+6K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+6K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K261430TruLift Expandable SystemLife Spine, Inc.20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+6K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+6K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+6K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K260660SABER-C SystemElevation Spine20261—
+6K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+6K250560BEE HANGMedical GmbH20250—
+6K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+6K250540SABER-C SystemElevation Spine20252—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+6K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+6K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+6K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+6K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+6K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+6K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+6K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+6K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+6K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+6K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+6K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+6K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+6K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+6K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+6K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+6K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+6K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+6K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+6K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+6K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+6K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+6K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+6K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K222004INTEGRATE -C Interbody Fusion SystemHappe Spine20236—
+6K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+6K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+6K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+6K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+6K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+6K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—