510(k) Report

Devices descending from K032705

615 later devices reach Distal Radius Fracture Repair System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K260038E3D™-C Interbody SystemEvolution Spine20261—
+11K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+11K251862External Fixation Bone DistractorParagon 28, Inc.20250—
+11K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+11K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+11K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+11K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+11K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+12K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+12K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+12K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+12K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+12K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+13K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+14K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—