510(k) Report

Devices descending from K180480

113 later devices reach ATEC Universal Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+5K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+5K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+6K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+6K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+6K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+7K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—