510(k) Report

Devices descending from K110694

227 later devices reach Concorde Bullet Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+9K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+10K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+10K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+10K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+10K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+10K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+10K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+10K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+10K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+10K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+11K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+11K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+11K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+11K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+11K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+11K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+11K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+11K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+12K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+12K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+12K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+12K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+12K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+13K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—