510(k) Report

Devices descending from K101278

111 later devices reach Inertia Pedicle Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+8K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—