510(k) Report

Devices descending from K210090

7 later devices reach Impulse AM Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+1K223418DeGen Impulse AM™ SystemDegen Medical20236—
+2K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+2K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+3K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+3K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+4K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—