510(k) Report

Devices descending from K091301

473 later devices reach Life Spine Stand-Alone Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+1K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+1K133827A-Link ZOsteo Vasive, LLC2014262
+1K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+1K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+2K201671A-Link ZAcuity Surgical Devices, LLC202125—
+2K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+2K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+2K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+3K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+3K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+3K222561AlignAcuity Surgical Devices, LLC202214—
+3K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+3K220610SOLO-LAurora Spine, Inc.20220—
+3K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+3K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+3K141942Midline II TICentinel Spine, Inc.2014459—
+4K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+4K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+4K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+4K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+4K232432E3D™-A Interbody SystemEvolution Spine20248—
+4K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+4K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+4K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+4K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+4K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+4K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+5K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+5K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K240368E3D™-A Interbody SystemEvolution Spine20247—
+5K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K201585Monterey AL Interbody SystemStryker Corporation202044
+5K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+5K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+5K181818Scarlet AL-TSpineart201864—
+5K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+5K180695FBC 921 (Alif)Fbc Device Aps20180—
+5K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+5K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+5K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+5K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+5K163595IMPIX 3D Print CagesMedicrea International SA2017282
+5K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+5K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+5K161379ELSA SpacersGlobus Medical, Inc.2016155—
+5K161129Pillar SA PTCOrthofix, Inc.201619—
+5K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+5K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+5K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+5K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+6K242589Scarlet® AL-TSpineart SA20240—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K230329F3D Interbody SystemCorelink, LLC20230—
+6K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+6K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+6K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+6K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+6K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+6K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+6K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+6K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+6K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+6K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+6K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+6K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+6K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+6K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+6K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+6K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—