510(k) Report

Devices descending from K223418

6 later devices reach DeGen Impulse AM™ System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+1K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+2K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+2K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+3K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+3K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—