510(k) Report

Devices descending from K080407

296 later devices reach Blackstone SFS Parallel Rod Connectors through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+6K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+6K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+6K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+6K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+6K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+6K182240PASS LP Spinal SystemMedicrea International SA20182—
+6K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+6K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+6K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+6K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+6K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+6K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K162764Jazz Frame SystemImplanet, S.A.20176—
+6K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+6K153404Zavation Spinal SystemZavation, LLC20161—
+6K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+6K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+6K141850Flospine Pedicle Screw SystemFlospine20140—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K252437JAZZ Spinal SystemImplanet20250—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+7K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+7K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+7K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+7K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+7K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+7K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+7K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+7K191217Jazz PFImplanet, S.A.20190—
+7K190376PASS LP Spinal SystemMedicrea International SA201915
+7K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+7K171881JAZZ Passer BandImplanet, S.A.20170—
+7K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+7K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+8K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+8K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+8K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+9K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+9K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+9K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+9K232432E3D™-A Interbody SystemEvolution Spine20248—
+9K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+9K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+9K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+9K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+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—
+10K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+10K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+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—
+10K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+10K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+10K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+10K241846E3D™-C Interbody SystemEvolution Spine20246—
+10K240368E3D™-A Interbody SystemEvolution Spine20247—
+10K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+10K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+10K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+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—
+11K262094E3D™-C Interbody SystemEvolution Spine20260—
+11K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+11K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+11K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+11K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+11K260038E3D™-C Interbody SystemEvolution Spine20261—
+11K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+11K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+11K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+11K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+11K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+11K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+11K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+11K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+12K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—