510(k) Report

Devices descending from K123476

5 later devices reach Mega 5.5 Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd.20174—
+2K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+3K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+3K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+4K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—