510(k) Report

Devices descending from K010972

262 later devices reach Isola Band Clamp through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+7K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K210549ARx Spinal SystemLife Spine, Inc.20211—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K200896Solstice CCILife Spine, Inc.20200—
+7K193129Yukon OCT Spinal SystemK2m, Inc.202001
+7K183381Navigation Enabled InstrumentsStryker20191—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+8K201006K2M Navigation InstrumentsK2m, Inc.20200—
+9K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+9K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+9K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+9K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+9K240368E3D™-A Interbody SystemEvolution Spine20247—
+9K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+9K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+9K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+10K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+10K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+10K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+10K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+10K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—