510(k) Report

Devices descending from K023835

1,227 later devices reach Devex Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K160715AccuLIF TL and PL CageStryker Corporation20160—
+8K141217Acculif TL and PL CageStryker Corporation20146423
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+9K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+9K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLC20222—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+9K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+10K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+10K230989Rod Registration FrameNu Vasive, Incorporated20230—
+11K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—