510(k) Report

Devices descending from K073351

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K133784Vista-S Device, Associated InstrumentationZimmer Trabecular Metal Technology201429—
+2K140066Infill CervicalPinnacle Spine Group, LLC20140—
+2K133653Anatomic Peek PTC Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.2014286—
+2K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+2K132596Proposed OptimusCustom Spine, Inc.201451
+2K140003Coroent Small Interbody SystemNuvasive, Inc.2014453—
+2K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+2K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+2K133192Mectalif TipeekMedacta International201416—
+2K130317Genesys Spine Apache Ibfd Star Cervical SystemGenesys Spine20139—
+2K133126K7 Lumbar SpacersK7, LLC20131—
+2K132718Integrity Spine Core SystemIntegrity Spine20131—
+2K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+2K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+2K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+2K131951Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.201312—
+2K121178Transcorp Acif SystemTranscorp, Inc.20130—
+2K131372Mobis IISignus Medizintechnik GmbH2013462—
+2K123909Aesculap Cespace XPAesculap Implant System, Inc.20137—
+2K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+2K123969XiphosDifusion Technologies201314—
+2K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013454—
+2K123388K7C SpacerK7, LLC20130—
+2K122630IN:C2 Spinal Fixation SystemSpine Smith Partners L.P.2012405—
+2K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+2K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+2K122021Sterispine LC CageSafe Orthopaedics20122—
+2K120819Stalif CCentinel Spine, Inc.2012206—
+2K122444Cervical CageEisertech, LLC201222—
+2K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+2K113561TM Ardis Interbody System TM Ardis Interbody System InstrumenationZimmer Trabecular Metal Technology20124762
+2K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+2K110632Lucent or Lucent MagnumSpinal Elements, Inc.20126941
+2K112801Ayers Rock Cervical CageQualgenix20122—
+2K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+2K120576Zavation Ibf SystemZavation, LLC201232—
+2K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+2K113518Arena-C Cervical Intervertebral Body Fusion SystemSpinefrontier, Inc.2012193—
+2K112862Mecta-CMedacta International201114—
+2K111119Trabecular Metal (TM) Fusion DeviceZimmer Spine, Inc.201152—
+2K111983Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxZimmer Trabecular Metal Technology201131—
+2K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+2K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+2K110659Medical Concepts Interbody Fusion SystemMedical Concepts, Inc.20111—
+2K111835Plateau Spacer SystemLife Spine, Inc.2011120—
+2K110864Biospine VBR SystemAesculap Implant Systems, LLC201149—
+2K110177Helena SystemRoyal Oak Medical Devices20110—
+2K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+2K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101371
+2K100889Endoskeleton TCTitan Spine, LLC2010455—
+3K2530413d Cage CervicalFims Co., Ltd.20260—
+3K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+3K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+3K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+3K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+3K261067BEE PLIF CageNGMedical GmbH20260—
+3K253260ORIO-3D Cage SystemSpineCraft20260—
+3K242303MOD-COrthomod, LLC20260—
+3K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+3K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+3K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+3K251016MectaLIF 3D MetalMedacta International S.A.20250—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+3K241073DZ-Tabone Intervertebral Body Fusion DeviceShenzhen Dazhou Medical Technology Co., Ltd.20240—
+3K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+3K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+3K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+3K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+3K240699SCARLET® AC-TiSpineart SA20240—
+3K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+3K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+3K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+3K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+3K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+3K222004INTEGRATE -C Interbody Fusion SystemHappe Spine20236—
+3K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K230583Tryptik TiSpineart SA20231—
+3K223043The Integrity Spine Core SystemIntegrity Spine20230—
+3K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+3K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+3K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+3K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+3K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+3K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+3K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+3K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+3K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+3K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+3K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K210573Velofix SA Cervical CageU&I Corporation20211—
+3K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+3K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—