510(k) Report

Devices descending from K981372

710 later devices reach Synthes 3.0 MM PC-Fix System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+10K251862External Fixation Bone DistractorParagon 28, Inc.20250—
+10K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+10K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+10K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+11K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+11K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+11K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+12K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+13K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—