510(k) Report

Devices descending from K092211

450 later devices reach Chesapeake Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+9K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+9K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+9K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+9K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+9K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+9K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+9K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+9K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+9K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+9K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+9K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+9K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+9K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+10K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+10K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+10K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+10K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+10K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+10K243474MagnetOs MISKuros Biosciences B.V20250—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+10K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+10K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+10K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+10K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+10K240453ReBOSSISOrthorebirth Co., Ltd.202402
+10K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+10K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+10K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+10K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+10K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+10K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+10K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+10K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+10K183092Kuros TLIF CageKuros Biosciences B.V20190—
+11K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+11K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+11K261408SABER-XA SystemElevation Spine20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+11K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+11K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+11K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+11K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+11K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+12K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—