510(k) Report

Devices descending from K983583

965 later devices reach Depuy Acromed Moss and Moss Miami Spinal Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+8K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+8K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+8K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+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—
+8K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+8K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+8K233684TriALTIS™ Spine SystemMedos International SARL20234—
+8K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+8K230026SqualeImplanet, S.A.20230—
+8K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+8K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+8K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+8K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+8K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+8K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+8K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+8K211306LabyrinthZavation Medical Products, LLC20213—
+8K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+8K200896Solstice CCILife Spine, Inc.20200—
+8K193129Yukon OCT Spinal SystemK2m, Inc.202001
+8K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+8K183381Navigation Enabled InstrumentsStryker20191—
+8K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+9K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+9K242042TriALTIS™ Spine SystemMedos International SARL20241—
+9K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+9K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+9K233366SYMPHONY OCT SystemMedos International SARL20230—
+9K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+9K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+9K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+9K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+10K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+10K250769Dakota LP SystemPrecision Spine, Inc.20250—
+10K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+10K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+10K230329F3D Interbody SystemCorelink, LLC20230—
+11K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+12K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—