510(k) Report

Devices descending from K081730

705 later devices reach Novel Cervical Spinal Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182477Cervical SpacerAdditive Implants, LLC201915—
+1K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+1K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+1K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+1K133784Vista-S Device, Associated InstrumentationZimmer Trabecular Metal Technology201429—
+1K133321Alamo CAlliance Partners, LLC20143—
+1K121178Transcorp Acif SystemTranscorp, Inc.20130—
+1K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+1K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+1K110915Cervical CageEisertech, LLC201123—
+1K110585Captiva Spine Fuselox Cervical CageCaptiva Spine, Inc.20111—
+1K100698STCCCardinal Spine, LLC2011346—
+1K102449Bright Spine Galileo Spinal Spacer SystemBright Spine, Inc.20110—
+1K092794Transcorp Acif SystemTranscorp, Inc.20104—
+1K092336C-Thru Spinal SystemEbi, L.P.2009492—
+1K083118Spinal Usa Anterior Cervical Interbody Fusion DeviceSpinal USA2009458—
+2K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+2K222004INTEGRATE -C Interbody Fusion SystemHappe Spine20236—
+2K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+2K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+2K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+2K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+2K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+2K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+2K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+2K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+2K173128Alamo® CAlliance Partners, LLC20182—
+2K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+2K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+2K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+2K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+2K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+2K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+2K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+2K142586Captiva Spine FuselOX Cervical IBF SystemCaptiva Spine20150—
+2K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc.201519—
+2K140280ForticoreNanovis, LLC20149—
+2K140003Coroent Small Interbody SystemNuvasive, Inc.2014453—
+2K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+2K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+2K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+2K122444Cervical CageEisertech, LLC201222—
+2K121320C7 Anterior Cervical Intervertebral Fusion CageMedyssey Co, Ltd.20122—
+2K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+2K111983Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxZimmer Trabecular Metal Technology201131—
+2K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+2K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+3K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+3K260038E3D™-C Interbody SystemEvolution Spine20261—
+3K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+3K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+3K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+3K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+3K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+3K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+3K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+3K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+3K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+3K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+3K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+3K212358Romero Cervical CageSpineup, Inc.20226—
+3K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+3K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+3K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+3K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+3K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+3K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+3K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+3K201287Impulse Interbody Fusion SystemDegen Medical20208—
+3K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+3K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+3K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+3K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+3K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+3K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+3K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+3K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+3K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+3K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+3K171312FortiCore®Nanovis, LLC20183—
+3K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+3K172419Velofix™ TLIF CageU&I Corporation20172—
+3K172424Velofix™ SA Cervical CageU&I Corporation201751
+3K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+3K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+3K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+3K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+3K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+3K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+3K153665Prow Fusion-LNlt Spine, Ltd.20160—
+3K152622Alta ACDF SystemBiomet Spine20160—