510(k) Report

Devices descending from K082320

302 later devices reach Darco Small Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—