510(k) Report

Devices descending from K080728

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+12K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+12K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—