510(k) Report

Devices descending from K962628

905 later devices reach Moss Miami Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K070368Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal SystemStryker Corp.200787—
+3K062836Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc.200650—
+3K061813Mantis Spinal SystemStryker Spine20061352
+3K062407Gateway Thoracolumbar Plate SystemGlobus Medical, Inc.2006127—
+3K061854Xia Titanium Spinal System and Xia Stainless Steel Spinal SystemStryker Spine2006216—
+3K060979Xia Titanium and 4.5 Spinal SystemsStryker Spine2006710—
+4K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd.20260—
+4K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+4K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+4K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K232628VADER® Pedicle SystemIcotec AG20241—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+4K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC20230—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K231658VEOS Spinal Fixation SystemSpineway20230—
+4K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+4K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+4K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+4K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+4K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+4K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+4K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…Dio Medical Corporation20222—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+4K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+4K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+4K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+4K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K203452Nano FortiFix® SystemNanovis, LLC20200—
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+4K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+4K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+4K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+4K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+4K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+4K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+4K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+4K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+4K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+4K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+4K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+4K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+4K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+4K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+4K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+4K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+4K173131Rexious Spinal Fixation SystemHuvexel Co., Ltd.20175—
+4K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—