510(k) Report

Devices descending from K022949

867 later devices reach Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K121250OP Spine SystemOrthoPediatrics Corp.201218—
+3K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+3K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+3K113361Securis Spinal FixationCumtom Spine20120—
+3K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+3K111457CD Horizon Spinal SystemMedtronic Sofamor Danek2011261—
+3K111449Revolve Additional ImplantsGlobus Medical, Inc.2011236—
+3K111479Revere CrosstopGlobus Medical, Inc.2011232—
+3K110348Universal Clamp Spinal Fixation SystemZimmer Spine201144—
+3K110280Revlok Fenestrated Screw SystemGlobus Medical, Inc.201195—
+3K110070TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc.2011269—
+3K103072Revere Sacral PlatesGlobus Medical, Inc.2011233—
+3K101471Axle Interspinous Fusion SystemX-Spine Systems, Inc.2010261
+3K100788Cocr RodsGlobus Medical, Inc.2010374—
+3K093294Revere Stabilization SystemGlobus Medical, Inc.2010376—
+3K091782Revere 6.35 Stabilization SystemGlobus Medical, Inc.2009404—
+3K092108Truss Thoracolumbar Plate SystemGlobus Medical, Inc.200942—
+3K073439Transition Stabilization SystemGlobus Medical, Inc.20092—
+3K083416Revolve Stabilization SystemGlobus Medical, Inc.2009297—
+3K081195Revere Uniplanar ScrewsGlobus Medical, Inc.2008405—
+3K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+3K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+3K073172Beacon Stabilization SystemGlobus Medical, Inc.2007376—
+3K062836Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc.200650—
+3K062407Gateway Thoracolumbar Plate SystemGlobus Medical, Inc.2006127—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd.20260—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+4K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+4K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K233256Robotic Integration InstrumentsDePuy Synthes20240—
+4K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+4K231515MySpine Cervical GuidesMedacta International S.A.20230—
+4K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+4K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+4K232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospine20230—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+4K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+4K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+4K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+4K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+4K223273ASTRA Spine SystemSpinecraft, LLC20228—
+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—
+4K221244CD Horizon™ Spinal SystemMedtronic202220—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+4K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+4K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+4K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+4K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+4K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+4K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+4K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+4K201006K2M Navigation InstrumentsK2m, Inc.20200—
+4K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+4K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+4K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+4K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+4K193219G Surgical Marksman SystemG Surgical, LLC20191—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+4K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+4K190376PASS LP Spinal SystemMedicrea International SA201915
+4K190361Zavation Spinal SystemZavation Medical Products, LLC20190—