510(k) Report

Devices descending from K033312

277 later devices reach Ebi Top Loading Mas Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+6K223418DeGen Impulse AM™ SystemDegen Medical20236—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K223273ASTRA Spine SystemSpinecraft, LLC20228—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K213417Ghost Spacer SystemLife Spine, Inc.20220—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K212358Romero Cervical CageSpineup, Inc.20226—
+6K211323ASTRA Spine SystemSpinecraft, LLC202112—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+6K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+6K162786PASS LP Spinal SystemMedicrea International SA20176—
+6K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+6K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K230026SqualeImplanet, S.A.20230—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+7K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+7K182240PASS LP Spinal SystemMedicrea International SA20182—
+7K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K252322SIros-X SystemGenesys Spine20250—
+8K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+8K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—