510(k) Report

Devices descending from K061563

275 later devices reach Ebi Array Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110321Tiger Spine SystemCorelink, LLC201183—
+1K0902035.5 Helical Flange Spinal System, Polaris ComponentsEbi, L.P.2009154—
+1K090523Polaris Spinal SystemEbi, L.P.2009156—
+1K081952Synergy Spinal System (6.35 Polaris)Biomet Spine2008255—
+1K062685Ebi Aray Spinal SystemEbi, L.P.2006281
+2K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+2K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+2K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+2K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+2K133369Tiger Spine SystemCorelink, LLC201429—
+2K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+2K131250Tiger Spine SystemCorelink, LLC201340—
+2K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+2K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+2K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+2K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+2K120696Tiger Spine SystemCorelink, LLC201241—
+2K113058Tiger Spine SystemCorelink, LLC201281—
+2K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+2K103393Polaris Spinal SystemBiomet Spine2011104—
+2K100409Polaris Spinal System, Polaris/Synergy Structue Anterior Fixation SystemBiomet Spine (Aka Ebi, LLC)2010144—
+2K100438Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation SystemEbi, L.P.2010104—
+2K100220Polaris Spinal SystemEbi, L.P.2010153—
+2K070385TI-Tamed Spinal SystemTi-Tamed (Pty), Ltd.20090—
+2K090320Conquest Spinal SystemLife Spine20092—
+2K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+3K220025ARx® Spinal SystemLife Spine, Inc.20220—
+3K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+3K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+3K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+3K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+3K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+3K193219G Surgical Marksman SystemG Surgical, LLC20191—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+3K180433Ennovate®Aesculap Implant Systems, LLC201811
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+3K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+3K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K151977icotec Pedicle SystemIcotec AG201630—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K151974Polaris Spinal SystemBiomet Spine201516—
+3K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+3K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+3K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+3K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+3K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+3K130655Response Spine SystemOrthoPediatrics Corp.201317—
+3K121630Range Spinal SystemK2m, Inc.2012127—
+3K121250OP Spine SystemOrthoPediatrics Corp.201218—
+3K110906Apex Spine SystemSpinecraft, LLC2011103—
+3K080767Conquest Spinal SystemLife Spine200821—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+4K222789VADER® Pedicle System, G21 CementIcotec AG202352
+4K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+4K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K203023Pisces Spinal SystemOrtho Development Corporation20210—
+4K203452Nano FortiFix® SystemNanovis, LLC20200—
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+4K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+4K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+4K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+4K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+4K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162