510(k) Report

Devices descending from K983583

965 later devices reach Depuy Acromed Moss and Moss Miami Spinal Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+6K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+6K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243693NEO Pedicle Screw System™Neo Medical SA20240—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+6K240160EGPS Navigated InstrumentsAstura Medical20240—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+6K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K232628VADER® Pedicle SystemIcotec AG20241—
+6K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+6K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+6K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+6K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+6K223558CUVIS-spineCurexo, Inc.20230—
+6K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+6K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+6K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+6K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+6K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+6K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+6K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+6K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+6K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+6K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+6K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+6K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+6K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+6K201569CUVIS-spineCurexo, Inc.20212—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+6K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+6K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K201287Impulse Interbody Fusion SystemDegen Medical20208—
+6K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+6K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+6K201006K2M Navigation InstrumentsK2m, Inc.20200—
+6K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+6K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+6K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+6K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+6K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+6K191217Jazz PFImplanet, S.A.20190—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+6K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+6K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+6K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+6K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+6K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+6K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+6K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+6K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+6K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+6K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+6K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+6K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+6K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+6K172194Connector SystemOrthofix, Inc.2017162
+6K171881JAZZ Passer BandImplanet, S.A.20170—
+6K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—