510(k) Report

Devices descending from K073351

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+3K152011Lucent Intervertebral Body Fusion DeviceSpinal Elements, Inc.2016106—
+3K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+3K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+3K160528ANATOMIC PEEK PTC Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201623—
+3K160291Optimus ALIF SystemAmendia, Inc.20160—
+3K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+3K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+3K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+3K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+3K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+3K151756Sterispine LC CageSafe Orthopaedics20150—
+3K150481Cascadia Interbody SystemK2m, Inc.20154593
+3K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+3K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+3K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+3K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+3K143740Battalion Universal Spacer SystemAlphatec Spine, Inc.2015247—
+3K150061Lucent; Lucent Ti-Bond SystemsSpinal Elements, Inc.2015135—
+3K142744Mecta-C TiPEEKMedacta International201512—
+3K142392Zavation Posterior LEIFZavation, LLC20150—
+3K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+3K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+3K141798Sypher Spacer SystemBiogennix, LLC20151—
+3K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc.201519—
+3K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+3K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+3K142328nvcNvision Biomedical Technologies, LLC20144—
+3K142271Zavation Z-Link LumbarZavation, LLC20149—
+3K142594nva, nvp, nvtNvision Biomedical Technologies, LLC20144—
+3K141537IN:C2 Spinal Fixation SystmeSpine Smith Holdings, LLC20140—
+3K142150Ais Modulift VBR SystemAesculap Implant System, Inc.201447—
+3K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014449—
+3K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+3K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+3K140319Coroent TI-C SystemNuvasive, Inc.2014590—
+3K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+3K141005Z-Link CervicalZavation, LLC20144—
+3K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+3K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014444—
+3K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+3K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+3K133200Stalif C (R)Centinel Spine, Inc.201410—
+3K133802Ais Modulift VBR SystemAesculap Implant System, Inc.201448—
+3K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+3K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+3K133893Sterispine LC CageSafe Orthopaedics20141—
+3K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+3K133967Interbody Cage SystemAurora Spine2014227—
+3K130913Genesys Spine Apache Lateral Lumbar Interbody Fusion SystemGenesys Spine201314—
+3K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+3K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+3K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+3K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+3K123602TM Ardis Interbody System InserterZimmer Trabecular Metal Technology20131—
+3K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+3K122967LucentSpinal Elements, Inc.2013615—
+3K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+3K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+3K120401Alamo TAlliance Partners, LLC20121—
+3K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+3K120024Mectalif TransforaminalMedacta International S.A.201223—
+3K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+4K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+4K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+4K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K261279DeltaNEC Interbody SystemNexus Spine20260—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+4K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+4K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+4K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+4K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+4K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+4K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—
+4K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+4K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+4K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+4K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+4K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+4K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+4K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+4K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+4K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+4K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+4K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+4K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+4K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+4K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+4K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+4K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—