510(k) Report

Devices descending from K944756

491 later devices reach Isola Open and Closed Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+7K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+7K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+7K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+8K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+8K253331PressON Spinal Fixation SystemNexus Spine20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K242042TriALTIS™ Spine SystemMedos International SARL20241—
+8K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+8K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+8K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+8K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+8K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+8K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+8K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+8K200896Solstice CCILife Spine, Inc.20200—
+8K193129Yukon OCT Spinal SystemK2m, Inc.202001
+8K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+8K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+8K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+8K183381Navigation Enabled InstrumentsStryker20191—
+8K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+8K182470Plateau Spacer SystemLife Spine20180—
+8K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+9K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K262094E3D™-C Interbody SystemEvolution Spine20260—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K260038E3D™-C Interbody SystemEvolution Spine20261—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+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—
+9K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+9K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+9K232432E3D™-A Interbody SystemEvolution Spine20248—
+9K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+9K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+9K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+9K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+9K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+9K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+9K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+9K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+10K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+10K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+10K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+10K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+10K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+10K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+10K240368E3D™-A Interbody SystemEvolution Spine20247—
+10K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+10K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+10K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+10K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+10K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+10K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+11K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+11K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+11K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+11K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+11K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+11K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—