510(k) Report

Devices descending from K941213

78 later devices reach Songer Cable System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181799ResCUBE™ Ligament Fixation SystemCousin Biotech Sas20180—
+1K153348Jazz LockImplanet, S.A.201610—
+1K153242Frontier Medical Devices In-Line Orthopedic Cable Cerclage SystemFrontier Medical Devices, Inc.20160—
+1K151888Frontier Medical Devices In-line Orthopedic Cable Cerclage SystemFrontier Medical Devices, Inc.20151—
+1K993286Pioneer Silicoat Sternal CablePioneer Surgical Technology199964—
+2K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+2K180728Spinal Elements Cerclage SystemSpinal Elements, Inc.20181—
+2K171881JAZZ Passer BandImplanet, S.A.20170—
+2K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+2K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+2K101484Compressyn BandDallen Medical20115—
+2K051165KLS Martin Sternal TalonKLS-Martin L.P.200662—
+3K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+3K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+3K190289Karma® Fixation SystemSpinal Elements, Inc.20190—
+3K142484Sternal Closure SystemJace Medical, LLC20141—
+3K130431Compressyn BandDallen Medical, Inc.20134—
+3K122860KLS Martin Recon TalonKLS Martin L.P.201210—
+3K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.200761—
+4K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K210290JACE Medical Thoracic Plating SystemJace Medical, LLC20210—
+4K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.20169—
+4K151983KLS Martin LSS Plating SystemKLS Martin L.P.201645—
+4K133858Tensyn BandDallen Medical, Inc.20143—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.20240—
+5K222397KLS Martin Level One Rib Fixation SystemKLS-Martin L.P.20233—
+5K221938KLS Martin Pure Pectus SystemKLS Martin L.P.20236—
+5K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices202139—
+5K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+6K261892ProRib Fixation SystemCosta Surgical, Inc.20260—
+6K253660KLS Martin Pure Pectus SystemKLS-Martin L.P.20260—
+6K243357CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20252—
+6K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K211695Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20211—
+6K143092Tensyn PlugDallen Medical, Inc.20151—
+7K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20260—
+7K250892CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20251—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+7K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+7K150359Tensyn PlugDallen Medical, Inc.20150—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K240368E3D™-A Interbody SystemEvolution Spine20247—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+8K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+8K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+8K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+9K262094E3D™-C Interbody SystemEvolution Spine20260—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K260038E3D™-C Interbody SystemEvolution Spine20261—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+9K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+9K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+10K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+10K242517ProAM ACDF SystemPro Surgical, Inc.20240—