510(k) Report

Devices descending from K033961

250 later devices reach Altius Oct System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142558Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m20140—
+1K141284Caspian Spinal SystemK2m, Inc.20140—
+1K133698Synapse SystemSynthes USA Products, LLC20146—
+1K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+1K103232Caspian Spinal SystemK2m, Inc.201146—
+1K100409Polaris Spinal System, Polaris/Synergy Structue Anterior Fixation SystemBiomet Spine (Aka Ebi, LLC)2010144—
+1K100438Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation SystemEbi, L.P.2010104—
+1K091359Gso PCT Spinal SystemGold Standard Orthopaedics, LLC20090—
+1K072729SierraSeaspine, Inc.20085—
+1K080526Sierra SystemSeaspine, Inc.20089—
+1K071905Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20076—
+1K061943Anatomica Posterior Cervical Fixation SystemAnatomica AB20072—
+1K062934SierraSeaspine, Inc.200621—
+2K231654NorthStar OCT SystemSeaspine, Inc.20230—
+2K193615NorthStar™ OCT Spinal SystemSeaSpine Orthopedics Corporation20201—
+2K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+2K140734Nextgen Altius Oct SystemEbi, LLC20140—
+2K141897Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC20145—
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+2K132122Kestrel Posterior Cervical Spine SystemOmni Surgical, LLC Dba Spine36020141—
+2K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+2K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+2K122163Certex Spinal Implant SystemX-Spine Systems, Inc.20122—
+2K120998Solstice Cross ConnectorLife Spine20121—
+2K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+2K120467Spinal Elements Posterior Cervical/Thoracic Spinal SystemSpinal Elements, Inc.20121—
+2K121808Casian, 3.5/4.5 ConnectorsK2m, Inc.20121—
+2K120656Everest Spinal SystemK2m, Inc.201243—
+2K113434Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20111—
+2K112025Sure Lok Mini Posterior Cervical/Upper Thoracic SystemSpinal USA20114—
+2K110906Apex Spine SystemSpinecraft, LLC2011103—
+2K103040Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20112—
+2K092656Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20095—
+3K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K162575Z-LINKPC SystemZavation, LLC20173—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K160428Certex Spinal Fixation SystemX-Spine Systems, Inc.20160—
+3K152211PCT SystemCentinel Spine, Inc.20150—
+3K151974Polaris Spinal SystemBiomet Spine201516—
+3K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc.20153—
+3K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+3K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC20153—
+3K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K140529Everest Spinal SystemK2m, LLC201431—
+3K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+3K131833Centurion Poct SystemOrthofix, Inc.20142—
+3K133094Certex Oct Spinal Implant SystemX-Spine Systems, Inc.20131—
+3K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+3K132603Apex Spine SystemSpinecraft, LLC201325—
+3K132757Everest Spinal SystemK2m, Inc.201341—
+3K131427LOTUSSpinal Elements, Inc.20130—
+3K132361Everest Spinal SystemK2m, Inc.201334—
+3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+3K113058Tiger Spine SystemCorelink, LLC201281—
+3K100888Modification to Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20103—
+3K100191Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20103—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+4K213394Vy Spine™ VySpan™ PCT SystemVy Spine, LLC20212—
+4K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+4K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+4K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+4K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K173508Everest Spinal SystemK2m20189—
+4K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+4K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+4K162300Reform® POCT SystemPrecision Spine, Inc.20162—
+4K151977icotec Pedicle SystemIcotec AG201630—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K150417Astra Spine SystemSpinecraft, LLC201521—
+4K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+4K142360Everest Spinal SystemK2m, Inc.201522—
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—