510(k) Report

Devices descending from K083857

902 later devices reach LDR Spine Roi-C Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—