510(k) Report

Devices descending from K073351

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191812ADI Cervical Interbody Fusion DeviceAdditive Device, Inc. (Adi) D/B/A Restor3D20192—
+1K173148ACIFColigne AG20171—
+1K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+1K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+1K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+1K143479Bluefin Interbody SystemTides Medical20152—
+1K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+1K133218Crystal ®; Mosaic ®; Vertu ®Spinal Elements, Inc.2014130—
+1K133815Intess Cervical Cage SystemKalitec Direct, LLC20144—
+1K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+1K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+1K122588Vusion CS PlusOrtho Development Corp.2013206—
+1K112664Zavation Ibf SystemsZavation, LLC201137—
+1K112036Calix PC Spinal Implant SystemX-Spine Systems, Inc.2011775—
+1K110733Daytona Anterior Cervical CageSpinenet, LLC20114811
+1K110915Cervical CageEisertech, LLC201123—
+1K102606Avs Anchor-C Cervical Cage SystemStryker Spine20113841
+1K103660Lanx Cervical Intervertebral Body Fusion SystemLanx, Inc.201141—
+1K103033Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx and 08-100-XxxxxZimmer Trabecular Metal Technology2011505—
+1K102322Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant…Omni Surgical, L.P.20116—
+1K093093Small Plateau Spacer SystemLife Spine2010393—
+1K101812Construx Mini Peek Spacer SystemOrthofix, Inc.2010291—
+1K091873Tryptik CA Anterior Intersomatic Cervical Cage, Models Mos-CA 12 05-S, Mos-CA 12 O6-SSpineart2009106—
+1K083118Spinal Usa Anterior Cervical Interbody Fusion DeviceSpinal USA2009458—
+1K090064Eminent Spine Interbody Fusion SystemEminent Spine20097011
+1K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009554—
+1K080971Spinesmith Cimplicity Spinal SystemSpine Smith Partners L.P.2008406—
+2K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+2K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+2K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+2K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+2K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+2K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+2K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+2K230219Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC20234—
+2K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+2K212701Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine20235—
+2K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+2K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+2K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+2K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+2K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+2K200312Tryptik TiSpineart20202—
+2K192906Mecta-C Stand AloneMedacta International S.A.20201—
+2K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+2K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+2K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+2K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC20190—
+2K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+2K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+2K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+2K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+2K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+2K181471ACCUFUSE Cervical SystemAbsolute Advantage Medical, LLC20180—
+2K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+2K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+2K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC201801
+2K172480icotec Interbody Cage SystemIcotec AG20185—
+2K173453Valeo® C+CSC with Lumen Interbody Fusion DeviceAmedica Corp.20180—
+2K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+2K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+2K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+2K172330Blustone Synergy Silica SystemBlustone Synergy20170—
+2K172424Velofix™ SA Cervical CageU&I Corporation201751
+2K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+2K172065Scarlet AC-TSpineart20172—
+2K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+2K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+2K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+2K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+2K163494Summit Spine Channel Cervical Interbody Fusion SystemSummit Spine20171—
+2K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+2K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+2K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+2K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+2K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+2K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)Evolution Spine, LLC20160—
+2K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC20162—
+2K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+2K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.201612—
+2K160324Cervical Interbody Fusion SystemEvolution Spine, LLC20162—
+2K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+2K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+2K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+2K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+2K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+2K143685Hedgehog Cervical Interbody Fusion DeviceVertera, Inc.201523—
+2K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+2K150812Genesys Spine Apache Cervical Interbody Fusion SystemGenesys Spine201512—
+2K150847Foundation Interbody DevicesCorelink, LLC201529—
+2K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+2K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+2K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+2K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+2K142041Porosteon Phusion Metal Cervical CagePorosteon, Inc.20141—
+2K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+2K142026Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.2014190—
+2K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+2K141337Arena-CSpinefrontier, Inc.20141—
+2K141129Exactech Cervical Spacer SystemExactech, Inc.20148—