510(k) Report

Devices descending from K990005

313 later devices reach Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+10K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+10K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+10K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+10K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+10K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+11K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+11K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+11K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+11K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+11K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+12K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—