510(k) Report

Devices descending from K043479

1,214 later devices reach MC+ Partial VBR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+9K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+9K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+9K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+9K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+9K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+9K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+9K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+10K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+10K230989Rod Registration FrameNu Vasive, Incorporated20230—
+10K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+11K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—