510(k) Report

Devices descending from K073351

1,154 later devices reach Crystal through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+4K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+4K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+4K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+4K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+4K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+4K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+4K142487Chesapeake Stabilization SystemK2m, Inc.201571
+4K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+4K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+4K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+4K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+4K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+4K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+4K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+4K1421124WEB Spinal Implant Products4Web, Inc.201433—
+4K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+4K140303Alamo TAlliance Partners, LLC20140—
+4K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+4K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+4K131671MectalifMedacta International201322—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K261049Scala® TLSpineart SA20260—
+5K261408SABER-XA SystemElevation Spine20260—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+5K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K262094E3D™-C Interbody SystemEvolution Spine20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K260506Ventana® P/T Lumbar Interbody SystemSpinal Elements, Inc.20260—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K260660SABER-C SystemElevation Spine20261—
+5K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+5K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+5K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+5K260038E3D™-C Interbody SystemEvolution Spine20261—
+5K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+5K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+5K250560BEE HANGMedical GmbH20250—
+5K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K250540SABER-C SystemElevation Spine20252—
+5K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+5K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K243188Cylox® STSignus Medizintechnik GmbH20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+5K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+5K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+5K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+5K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+5K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+5K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+5K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+5K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+5K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+5K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+5K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+5K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+5K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+5K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+5K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+5K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+5K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+5K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+5K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+5K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+5K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+5K223326Axiom PSR SystemRestor3D202301
+5K230026SqualeImplanet, S.A.20230—
+5K223418DeGen Impulse AM™ SystemDegen Medical20236—
+5K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+5K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+5K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+5K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+5K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+5K221172FOCUS Interbody SystemOc Medical Devices20220—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+5K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+5K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+5K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—