510(k) Report

Devices descending from K140759

204 later devices reach Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+11K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+11K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+12K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—