510(k) Report

Devices descending from K050624

892 later devices reach Stryker Spine Avs PL Peek Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K172083Idys™ ALIF SystemClariance, Sas20177—
+6K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+6K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+6K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+6K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+6K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+6K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+6K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+6K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+6K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+6K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+6K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+6K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+6K141942Midline II TICentinel Spine, Inc.2014459—
+6K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+6K1421124WEB Spinal Implant Products4Web, Inc.201433—
+6K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+6K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+6K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+7K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K263049SABER-C SystemElevation Spine20260—
+7K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+7K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+7K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+7K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+7K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+7K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+7K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+7K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+7K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+7K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+7K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K243188Cylox® STSignus Medizintechnik GmbH20250—
+7K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+7K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+7K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+7K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+7K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+7K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+7K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+7K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+7K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+7K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+7K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+7K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+7K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+7K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+7K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+7K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+7K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+7K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+7K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+7K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+7K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+7K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+7K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+7K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+7K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+7K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+7K223326Axiom PSR SystemRestor3D202301
+7K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+7K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+7K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+7K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+7K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+7K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+7K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+7K221172FOCUS Interbody SystemOc Medical Devices20220—
+7K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+7K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+7K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+7K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+7K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+7K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+7K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+7K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+7K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+7K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+7K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+7K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+7K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—