510(k) Report

Devices descending from K033109

1,218 later devices reach Ellys and Aurys Vertebral Body Replacements through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K173537Concorde Lift™Medos International SARL20181—
+9K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+10K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+10K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+10K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+10K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+10K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+10K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+10K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+11K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+11K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+11K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+11K230989Rod Registration FrameNu Vasive, Incorporated20230—
+11K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+12K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—