510(k) Report

Devices descending from K051027

908 later devices reach Stalif TT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+6K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+6K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+6K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+6K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+6K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+6K190885Elevation Spine Saber-C SystemElevation Spine201925—
+6K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+6K183243Velofix TLIF CageU&I Corporation20190—
+6K183064TxTi IBF SystemInnovasis, Inc.2019481
+6K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+6K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+6K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+6K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+6K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+6K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+6K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+6K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+6K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+6K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+6K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+6K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+6K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+6K180909REVEL SpacersGlobus Medical, Inc.201837—
+6K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+6K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+6K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+6K181829Velofix TLIF CageU&I Corporation20181—
+6K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+6K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+6K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+6K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+6K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+6K181014Tritanium PL CageStryker Spine2018137—
+6K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+6K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+6K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+6K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+6K172941CASCADIA Interbody SystemK2m201852—
+6K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+6K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+6K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+6K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+6K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+6K170235Lucent®Spinal Elements, Inc.2017107—
+6K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+6K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+6K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+6K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+6K171704CAPRI Corpectomy Cage SystemK2m201710—
+6K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+6K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+6K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+6K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+6K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+6K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+6K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+6K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+6K160715AccuLIF TL and PL CageStryker Corporation20160—
+6K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+6K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+6K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+7K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+7K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K260660SABER-C SystemElevation Spine20261—
+7K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+7K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+7K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+7K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K252322SIros-X SystemGenesys Spine20250—
+7K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+7K250540SABER-C SystemElevation Spine20252—
+7K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+7K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+7K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+7K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+7K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+7K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+7K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+7K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+7K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+7K240715Idys® C ZP 3DTiClariance20240—
+7K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+7K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+7K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+7K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—