510(k) Report

Devices descending from K053581

105 later devices reach Nuvasive Smartplate Gradient Plus System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—