510(k) Report

Devices descending from K090166

683 later devices reach Avs Anterior Large Peek Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+8K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+8K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+8K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+8K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+8K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+8K212562Idys-C ZP 3DTiClariance, SA20211—
+8K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+8K211413BEE PLIF CageNGMedical GmbH20211—
+8K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+8K211306LabyrinthZavation Medical Products, LLC20213—
+8K210728CONDUIT InstrumentsMedos International SARL20215—
+8K202032Idys LLIF 3DTiClariance, Sas20210—
+8K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+8K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+8K201287Impulse Interbody Fusion SystemDegen Medical20208—
+8K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+8K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+8K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+9K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+9K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+9K252742Navigated InstrumentsTyber Medical, LLC20251—
+9K252322SIros-X SystemGenesys Spine20250—
+9K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+9K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+9K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+9K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+9K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+9K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+9K240715Idys® C ZP 3DTiClariance20240—
+9K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+9K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+9K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+9K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+9K223418DeGen Impulse AM™ SystemDegen Medical20236—
+9K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+9K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+9K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+9K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+9K212358Romero Cervical CageSpineup, Inc.20226—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+9K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+10K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+10K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+10K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+10K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+10K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+10K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+10K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+10K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+10K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+10K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+10K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+10K230026SqualeImplanet, S.A.20230—
+10K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+11K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+11K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+11K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—