510(k) Report

Devices descending from K011037

1,374 later devices reach Vertebral Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K142392Zavation Posterior LEIFZavation, LLC20150—
+6K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+6K143616AccuLIF TL and PL CageStryker Corporation20154694
+6K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+6K1421124WEB Spinal Implant Products4Web, Inc.201433—
+6K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+6K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+6K140529Everest Spinal SystemK2m, LLC201431—
+6K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+6K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+6K133893Sterispine LC CageSafe Orthopaedics20141—
+6K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+6K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+6K133192Mectalif TipeekMedacta International201416—
+6K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+6K132757Everest Spinal SystemK2m, Inc.201341—
+6K132361Everest Spinal SystemK2m, Inc.201334—
+6K130445Vault Alif SystemSpinal USA20139—
+6K121320C7 Anterior Cervical Intervertebral Fusion CageMedyssey Co, Ltd.20122—
+6K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+6K111983Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxZimmer Trabecular Metal Technology201131—
+6K110226Interfuse T Invertebral Body Fusion DeviceVertebral Technologies, Inc.201190—
+6K100743Atlas Spine Pivoting SystemAtlas Spine, Inc.20104—
+6K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+7K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+7K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K253545Vulcan Spinal SystemK2m, Inc.20260—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+7K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+7K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+7K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+7K252742Navigated InstrumentsTyber Medical, LLC20251—
+7K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+7K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+7K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+7K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+7K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+7K243474MagnetOs MISKuros Biosciences B.V20250—
+7K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+7K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+7K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+7K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+7K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+7K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+7K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+7K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+7K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+7K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+7K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+7K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+7K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+7K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+7K240453ReBOSSISOrthorebirth Co., Ltd.202402
+7K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+7K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+7K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+7K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+7K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+7K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+7K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+7K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+7K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+7K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+7K223326Axiom PSR SystemRestor3D202301
+7K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+7K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+7K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—