510(k) Report

Devices descending from K080971

406 later devices reach Spinesmith Cimplicity Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K223326Axiom PSR SystemRestor3D202301
+10K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+11K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+11K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+12K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+12K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—