510(k) Report

Devices descending from K024060

857 later devices reach Modification to Asnis Iii Cannulated Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+9K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+9K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+9K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+9K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+9K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+9K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+9K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+9K202833Sequel External Fixation DeviceSequel Medical, Inc.20211—
+9K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+9K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+9K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+9K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+9K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+9K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+10K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+10K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+10K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.20260—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K250769Dakota LP SystemPrecision Spine, Inc.20250—
+10K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+10K251862External Fixation Bone DistractorParagon 28, Inc.20250—
+10K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+10K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+10K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+10K232432E3D™-A Interbody SystemEvolution Spine20248—
+10K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+10K221172FOCUS Interbody SystemOc Medical Devices20220—
+10K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+10K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+10K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+10K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+10K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+11K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+11K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+11K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+11K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+11K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+11K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+11K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+11K240368E3D™-A Interbody SystemEvolution Spine20247—
+11K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+11K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+11K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+11K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+11K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+11K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+11K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+11K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+12K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+12K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+12K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+12K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+12K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+12K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+13K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+13K242517ProAM ACDF SystemPro Surgical, Inc.20240—