510(k) Report

Devices descending from K980447

381 later devices reach Depuy Motech Moss Miami Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+7K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+7K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+7K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+7K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+7K162786PASS LP Spinal SystemMedicrea International SA20176—
+7K162764Jazz Frame SystemImplanet, S.A.20176—
+7K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+7K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+7K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+8K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+8K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K252437JAZZ Spinal SystemImplanet20250—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+8K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K191217Jazz PFImplanet, S.A.20190—
+8K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+8K182240PASS LP Spinal SystemMedicrea International SA20182—
+8K171881JAZZ Passer BandImplanet, S.A.20170—
+8K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+8K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+9K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+9K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+9K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+9K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+9K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+9K190376PASS LP Spinal SystemMedicrea International SA201915
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+10K232432E3D™-A Interbody SystemEvolution Spine20248—
+10K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+10K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+10K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+10K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+10K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+11K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+11K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+11K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+11K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+11K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+11K241846E3D™-C Interbody SystemEvolution Spine20246—
+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—
+12K262094E3D™-C Interbody SystemEvolution Spine20260—
+12K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+12K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+12K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+12K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+12K260038E3D™-C Interbody SystemEvolution Spine20261—
+12K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+12K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+12K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+12K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+12K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—