510(k) Report

Devices descending from K103033

505 later devices reach Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx and 08-100-Xxxxx through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+11K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—