510(k) Report

Devices descending from K201287

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+2K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+2K223418DeGen Impulse AM™ SystemDegen Medical20236—
+3K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+3K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+5K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—