510(k) Report

Devices descending from K073351

1,154 later devices reach Crystal through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K261430TruLift Expandable SystemLife Spine, Inc.20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+7K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+7K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—
+7K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+7K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K243474MagnetOs MISKuros Biosciences B.V20250—
+7K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+7K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+7K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+7K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+7K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+7K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+7K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+7K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+7K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+7K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+7K240453ReBOSSISOrthorebirth Co., Ltd.202402
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+7K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+7K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+7K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+7K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K223251Hexanium PLIFSpinevision, S.A.S.20220—
+7K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+7K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+7K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+7K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+7K222561AlignAcuity Surgical Devices, LLC202214—
+7K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+7K220610SOLO-LAurora Spine, Inc.20220—
+7K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+7K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+7K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+7K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+7K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+7K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+7K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K201087CORBEL SpacersGlobus Medical, Inc.202036—
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+7K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+7K193521Steerable Plateau TiLife Spine, Inc.20201—
+7K193258ProLift Expandable SystemLife Spine, Inc.20203—
+7K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+7K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+7K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+7K182349Concorde LiftMedos International SARL20190—
+7K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+7K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+7K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+7K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+7K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+7K173537Concorde Lift™Medos International SARL20181—
+7K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+7K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+7K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+7K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+7K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+8K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—