510(k) Report

Devices descending from K051205

829 later devices reach Stryker Spine Avs Asl Peek Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+10K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+10K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+10K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+10K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+10K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+10K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+10K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+10K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+10K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+10K182349Concorde LiftMedos International SARL20190—
+10K173537Concorde Lift™Medos International SARL20181—
+11K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+11K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+11K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+11K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+11K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+11K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+11K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+11K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+11K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+11K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+11K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+12K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+12K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+12K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+12K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—