510(k) Report

Devices descending from K062196

559 later devices reach SFX Snap-Fit Cross Connector through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252322SIros-X SystemGenesys Spine20250—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+5K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+5K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+5K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+5K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+5K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+5K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+5K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+5K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+5K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+5K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+5K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+5K222789VADER® Pedicle System, G21 CementIcotec AG202352
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+5K221244CD Horizon™ Spinal SystemMedtronic202220—
+5K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+5K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+5K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+5K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+5K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+5K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+5K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+5K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+5K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K203452Nano FortiFix® SystemNanovis, LLC20200—
+5K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+5K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+5K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+5K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+5K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+5K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+5K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+5K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+5K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+5K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+5K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+5K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+5K182240PASS LP Spinal SystemMedicrea International SA20182—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+5K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+5K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+5K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+5K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+5K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+5K171321K2M Navigation InstrumentsK2m201711
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+5K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+5K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+5K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+5K162921Navigated Instrument SystemOrthofix, Inc.20175—
+5K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+5K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+5K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+5K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+5K153404Zavation Spinal SystemZavation, LLC20161—
+5K151977icotec Pedicle SystemIcotec AG201630—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K151974Polaris Spinal SystemBiomet Spine201516—
+5K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+5K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+5K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+5K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+5K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+5K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+5K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+5K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+5K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+5K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+5K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511