510(k) Report

Devices descending from K020887

1,622 later devices reach Ebi Ais Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K130461Stalif XCentinel Spine, Inc.201313—
+7K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG20130—
+7K124034Mectalif AnteriorMedacta International201311—
+7K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+7K112700Frontier Sadl Interbody Fusion DeviceFrontier Medical Devices, Inc.20121—
+7K120869Anchor-L Lumbar CageStryker Spine2012638—
+7K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+7K122085Stingray Cervical CageOmni Surgical, LP Dba Spine36020120—
+7K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+7K122591Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.201214—
+7K121892Phantom Plus Ceramic Cage SystemAmedica Corp.20127—
+7K120991TRANS1 Interbody Fusion SystemTrans1 Incorporated2012172—
+7K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+7K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+7K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+7K113642Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA2012292—
+7K112405Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc.2011296—
+7K110063Sovereign Spinal SystemMedtronic Sofamor Danek, Inc.2011718—
+7K111626Endoskeleton (R) TasTitan Spine, LLC2011273—
+7K111525Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2011355—
+7K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+7K103655Octane-C Interbody Fusion Device SystemExactech, Inc.2011481
+7K103369Vault Alif SystemSpinal USA201110—
+7K093093Small Plateau Spacer SystemLife Spine2010393—
+7K101301Stalif MidlineCentinel Spine2010474—
+7K100889Endoskeleton TCTitan Spine, LLC2010455—
+7K083475Lucent MagnumSpinal Elements, Inc.2009834—
+7K081711Lucent Magnum+Spinal Elements, Inc.20080—
+8K263049SABER-C SystemElevation Spine20260—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+8K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+8K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+8K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+8K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+8K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K252742Navigated InstrumentsTyber Medical, LLC20251—
+8K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+8K253331PressON Spinal Fixation SystemNexus Spine20250—
+8K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+8K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+8K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+8K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+8K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+8K250556Porous Biologic ScaffoldVentris Medical20250—
+8K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+8K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+8K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+8K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K242589Scarlet® AL-TSpineart SA20240—
+8K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+8K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+8K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+8K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+8K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+8K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+8K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+8K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+8K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+8K240442MagnetOs PuttyKuros Biosciences B.V20243—
+8K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+8K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+8K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+8K240458Synthetic Bone PuttyVentris Medical20242—
+8K240459Cerament Bone Void FillerBonesupport AB20240—
+8K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+8K232347MagnetOs GranulesKuros Biosciences B.V20242—
+8K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+8K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+8K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+8K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+8K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+8K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+8K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+8K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+8K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+8K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+8K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+8K232315Catalyst Bone Void FillerOssdsign AB20237—
+8K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+8K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+8K223418DeGen Impulse AM™ SystemDegen Medical20236—
+8K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+8K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+8K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—