510(k) Report

Devices descending from K080401

840 later devices reach Shell Cage, Wave Cage, Loop Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+9K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+9K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+9K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+9K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+9K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+9K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+9K182349Concorde LiftMedos International SARL20190—
+9K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+9K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+9K173537Concorde Lift™Medos International SARL20181—
+9K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+10K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+10K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+10K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+10K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+10K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+10K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+10K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+10K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+10K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+10K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+10K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+10K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+11K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+11K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+11K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+11K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+11K230989Rod Registration FrameNu Vasive, Incorporated20230—
+11K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+11K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+11K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+12K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+12K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—