510(k) Report

Devices descending from K955348

1,019 later devices reach Titanium Moss Miami Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K183117PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.20184—
+7K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+7K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+7K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+7K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+7K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+7K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+7K172194Connector SystemOrthofix, Inc.2017162
+7K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+7K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+7K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+7K162764Jazz Frame SystemImplanet, S.A.20176—
+7K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+7K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+7K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+7K152174Sniper Spine SystemSpine Wave, Inc.20158—
+7K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+7K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+7K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+7K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+7K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc.2012151
+8K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+8K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.20260—
+8K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+8K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+8K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+8K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+8K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+8K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+8K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+8K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+8K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K253331PressON Spinal Fixation SystemNexus Spine20250—
+8K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+8K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243693NEO Pedicle Screw System™Neo Medical SA20240—
+8K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+8K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K233684TriALTIS™ Spine SystemMedos International SARL20234—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+8K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+8K230026SqualeImplanet, S.A.20230—
+8K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+8K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+8K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+8K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+8K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+8K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+8K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+8K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+8K211306LabyrinthZavation Medical Products, LLC20213—
+8K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+8K200896Solstice CCILife Spine, Inc.20200—
+8K193129Yukon OCT Spinal SystemK2m, Inc.202001
+8K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+8K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+8K191217Jazz PFImplanet, S.A.20190—
+8K190751Connector SystemOrthofix, Inc.20193—
+8K183381Navigation Enabled InstrumentsStryker20191—
+8K182470Plateau Spacer SystemLife Spine20180—
+8K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+8K171881JAZZ Passer BandImplanet, S.A.20170—
+8K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+8K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+8K160003Sniper (R) Spine SystemSpine Wave, Inc.20167—
+8K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+8K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+9K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+9K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+9K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+9K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+9K242042TriALTIS™ Spine SystemMedos International SARL20241—