510(k) Report

Devices descending from K030383

410 later devices reach Modification to Moss Miami Spinal System Polyaxial Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+6K231658VEOS Spinal Fixation SystemSpineway20230—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+6K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+6K222789VADER® Pedicle System, G21 CementIcotec AG202352
+6K223273ASTRA Spine SystemSpinecraft, LLC20228—
+6K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+6K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+6K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+6K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+6K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K201006K2M Navigation InstrumentsK2m, Inc.20200—
+6K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+6K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+6K190751Connector SystemOrthofix, Inc.20193—
+6K160003Sniper (R) Spine SystemSpine Wave, Inc.20167—
+6K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+6K151216Everest Spinal SystemK2m, Inc.201511—
+6K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+6K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+6K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+6K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+7K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+7K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+7K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+7K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+7K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+7K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+7K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K240368E3D™-A Interbody SystemEvolution Spine20247—
+7K240392JAZZ Spinal SystemImplanet20241—
+7K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+7K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+7K232628VADER® Pedicle SystemIcotec AG20241—
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+7K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+7K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+7K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+7K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+7K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+7K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+7K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+7K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+7K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+7K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+7K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+7K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+7K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+7K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+7K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+7K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+8K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, 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—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252322SIros-X SystemGenesys Spine20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K252437JAZZ Spinal SystemImplanet20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—