510(k) Report

Devices descending from K962628

905 later devices reach Moss Miami Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+8K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+8K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+8K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+8K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K242042TriALTIS™ Spine SystemMedos International SARL20241—
+8K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+8K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+8K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+8K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+8K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+8K223294SpineJack® Expansion KitStryker Instruments20221—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+8K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+8K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+8K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+8K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+8K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+8K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+8K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+8K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+8K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+8K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+8K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+8K172194Connector SystemOrthofix, Inc.2017162
+9K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+9K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+9K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K250637VCFix Spinal SystemAmber Implants20250—
+9K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+9K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+9K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+9K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+9K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+9K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+9K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+9K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+9K240368E3D™-A Interbody SystemEvolution Spine20247—
+9K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+9K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+9K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+9K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+9K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+9K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+9K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+9K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+9K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+9K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+9K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+9K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+9K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+9K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+9K211306LabyrinthZavation Medical Products, LLC20213—
+9K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+9K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+9K190751Connector SystemOrthofix, Inc.20193—
+10K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+10K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+10K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+10K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+10K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+10K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+10K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+10K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+10K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+10K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+10K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+10K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+10K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+11K250769Dakota LP SystemPrecision Spine, Inc.20250—
+11K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+11K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+11K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—