510(k) Report

Devices descending from K081636

542 later devices reach Peek-Optima Alif Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+7K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+7K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+7K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K240368E3D™-A Interbody SystemEvolution Spine20247—
+7K240699SCARLET® AC-TiSpineart SA20240—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+7K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+7K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+7K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+7K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+7K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+7K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+7K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+7K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+7K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+7K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+7K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+7K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+7K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K223326Axiom PSR SystemRestor3D202301
+7K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+7K221578Hexanium ACIFSpinevision, S.A.S.20224—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+7K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+7K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+7K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+7K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+7K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+7K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+7K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+7K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+7K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+7K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+7K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+7K201671A-Link ZAcuity Surgical Devices, LLC202125—
+7K200919Idys ALIF 3DTiClariance20210—
+7K202032Idys LLIF 3DTiClariance, Sas20210—
+7K203444BEE HA CageNGMedical GmbH20211—
+7K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+7K200316UNiD IB3D ALIFMedicrea International SA20200—
+7K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+7K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+7K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+7K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+7K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+7K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+7K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+7K191263Idys ALIF TiVacClariance, Sas20190—
+7K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+7K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+7K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+7K161379ELSA SpacersGlobus Medical, Inc.2016155—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+8K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K260660SABER-C SystemElevation Spine20261—
+8K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+8K253260ORIO-3D Cage SystemSpineCraft20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+8K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+8K250769Dakota LP SystemPrecision Spine, Inc.20250—
+8K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+8K252742Navigated InstrumentsTyber Medical, LLC20251—
+8K252322SIros-X SystemGenesys Spine20250—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K250540SABER-C SystemElevation Spine20252—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+8K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+8K241525ExcelsiusXR™Globus Medical, Inc.20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+8K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—