510(k) Report

Devices descending from K072791

1,055 later devices reach Oracle Spacer, Opal Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+3K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+3K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+3K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+3K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+3K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+3K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+3K230583Tryptik TiSpineart SA20231—
+3K223043The Integrity Spine Core SystemIntegrity Spine20230—
+3K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+3K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+3K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+3K213417Ghost Spacer SystemLife Spine, Inc.20220—
+3K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+3K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+3K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+3K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K200919Idys ALIF 3DTiClariance20210—
+3K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+3K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+3K201287Impulse Interbody Fusion SystemDegen Medical20208—
+3K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+3K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+3K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+3K192897icotec Cervical CageIcotec AG20201—
+3K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+3K192906Mecta-C Stand AloneMedacta International S.A.20201—
+3K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+3K193521Steerable Plateau TiLife Spine, Inc.20201—
+3K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+3K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+3K183407Triton CageMedyssey USA, Inc.20190—
+3K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+3K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+3K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+3K191263Idys ALIF TiVacClariance, Sas20190—
+3K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+3K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+3K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+3K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+3K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+3K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+3K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+3K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+3K181625Life Spine Resolute™ Threaded Cage SystemLife Spine, Inc.20180—
+3K182470Plateau Spacer SystemLife Spine20180—
+3K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+3K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+3K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+3K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+3K180695FBC 921 (Alif)Fbc Device Aps20180—
+3K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+3K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+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—
+3K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+3K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+3K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+3K171312FortiCore®Nanovis, LLC20183—
+3K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+3K172009Cascadia Interbody SystemK2m, Inc.2017433
+3K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+3K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+3K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+3K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+3K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+3K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+3K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+3K171140Matrixx SystemNexxt Spine, LLC2017145—
+3K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+3K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+3K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+3K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+3K162206Zavation IBFZavation, LLC201724—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+3K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+3K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—