510(k) Report

Devices descending from K033995

624 later devices reach 3.5 MM LCP Distal Humerus System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+9K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+10K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+10K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+10K262094E3D™-C Interbody SystemEvolution Spine20260—
+10K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+10K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+10K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+10K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.20260—
+10K260038E3D™-C Interbody SystemEvolution Spine20261—
+10K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+10K251862External Fixation Bone DistractorParagon 28, Inc.20250—
+10K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+10K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+10K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+10K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+10K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+11K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+11K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+11K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+11K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+11K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+12K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+13K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—