510(k) Report

Devices descending from K962236

548 later devices reach Scarf Thread-Head Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+8K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K242861TrueLok ElevateOrthofix Srl20243—
+8K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+8K233025Revolution External Plating SystemNew Standard Device Dba Metalogix20240—
+8K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+8K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+8K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+8K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+8K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+8K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+8K202833Sequel External Fixation DeviceSequel Medical, Inc.20211—
+8K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+8K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+8K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+8K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+8K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+8K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+9K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K262094E3D™-C Interbody SystemEvolution Spine20260—
+9K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.20260—
+9K260038E3D™-C Interbody SystemEvolution Spine20261—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K251862External Fixation Bone DistractorParagon 28, Inc.20250—
+9K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+9K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+9K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+9K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+9K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+9K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+10K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+10K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+10K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+10K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+10K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+10K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+10K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+11K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+11K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+12K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—