510(k) Report

Devices descending from K991407

709 later devices reach Synthes Locking Calcaneal Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K251862External Fixation Bone DistractorParagon 28, Inc.20250—
+9K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+9K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+9K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+10K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+10K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+10K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+11K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+12K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—