510(k) Report

Devices descending from K042930

1,440 later devices reach Spacevision Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+7K162496Foundation 3D InterbodyCorelink, LLC201782—
+7K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+7K162921Navigated Instrument SystemOrthofix, Inc.20175—
+7K163180Hubble IIOrbbo Surgical, LLC20160—
+7K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+7K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+7K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+7K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+7K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+7K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+7K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+7K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+7K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+7K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+7K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+7K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+7K153400ProLift Expandable SystemLife Spine, Inc.201672—
+7K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+7K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+7K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+7K152651AccuLIF TL and PL CageStryker Corporation201530—
+7K152304Tritanium PL CageStryker20154481
+7K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+7K143479Bluefin Interbody SystemTides Medical20152—
+7K151727Everest Spinal SystemK2m, Inc.201511—
+7K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+7K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+7K142360Everest Spinal SystemK2m, Inc.201522—
+7K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+7K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+7K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+7K133717Longbow Spacer SystemLife Spine20149—
+7K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+7K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+7K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+7K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+7K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+7K141147Range Spinal SystemK2m, Inc.20141—
+7K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+7K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+7K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+7K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+7K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+7K130194Acculif XL CageCoalign Innovations, Inc.20131—
+7K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+7K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+7K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+8K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+8K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+8K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+8K261430TruLift Expandable SystemLife Spine, Inc.20260—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+8K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+8K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+8K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+8K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+8K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+8K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+8K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+8K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+8K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K250769Dakota LP SystemPrecision Spine, Inc.20250—
+8K250560BEE HANGMedical GmbH20250—
+8K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+8K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+8K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+8K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K243474MagnetOs MISKuros Biosciences B.V20250—
+8K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+8K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+8K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+8K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+8K243188Cylox® STSignus Medizintechnik GmbH20250—
+8K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+8K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+8K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+8K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+8K241895Cannulated PsiFGuardSpineguard20240—
+8K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+8K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+8K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+8K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+8K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+8K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+8K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+8K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+8K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—