510(k) Report

Devices descending from K031100

508 later devices reach Synthes Ventrofix Mis System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+11K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+11K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+11K230026SqualeImplanet, S.A.20230—
+12K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+12K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+12K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+12K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—