510(k) Report

Devices descending from K141376

106 later devices reach Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—