510(k) Report

Devices descending from K982320

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+6K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+6K142360Everest Spinal SystemK2m, Inc.201522—
+6K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+6K132303Implanet Spine SystemImplanet, S.A.201315—
+6K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+6K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+6K123373Nautilus Spinal SystemLife Spine201317—
+6K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+6K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+6K111953Nautilus Spinal SystemLife Spine20123—
+6K120838Synthes Matrix SystemSynthes Spine201216—
+6K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc.2012151
+6K090320Conquest Spinal SystemLife Spine20092—
+7K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+7K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K252322SIros-X SystemGenesys Spine20250—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+7K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K240368E3D™-A Interbody SystemEvolution Spine20247—
+7K240392JAZZ Spinal SystemImplanet20241—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+7K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+7K233366SYMPHONY OCT SystemMedos International SARL20230—
+7K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+7K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+7K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+7K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+7K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+7K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+7K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+7K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+7K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+7K211323ASTRA Spine SystemSpinecraft, LLC202112—
+7K210549ARx Spinal SystemLife Spine, Inc.20211—
+7K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+7K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+7K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+7K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+7K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+7K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+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—
+7K153404Zavation Spinal SystemZavation, LLC20161—
+7K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+7K160003Sniper (R) Spine SystemSpine Wave, Inc.20167—
+7K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+7K151216Everest Spinal SystemK2m, Inc.201511—
+7K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+7K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+7K141850Flospine Pedicle Screw SystemFlospine20140—
+7K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+7K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+7K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K252437JAZZ Spinal SystemImplanet20250—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+8K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+8K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+8K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+8K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+8K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—