510(k) Report

Devices descending from K001668

450 later devices reach Global Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132218Perfix Iliac Screw SystemU&I Corporation20130—
+1K1216154CIS Vane Spine SystemSolco Biomedical Co., Ltd.20121—
+1K111995Xingtm Spine SystemImplanova Co., Ltd.20110—
+1K1024584CIS Solar Spine System and 4CIS Apollon Spine SystemSolco Biomedical Co., Ltd.20114—
+1K103085Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd.2011123—
+1K100706Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd.2010124—
+1K072436Mega Spine SystemBk Meditech, Co., Ltd.20079—
+1K0637084S Spinal SystemTaeyeon Medical Co., Ltd.20078—
+1K062513Apex Spine SystemSpinecraft, Inc.2006179—
+1K0607024CIS Vane Spine SystemSolco Biomedical Co., Ltd.2006166—
+1K053573GSS Pedicle Screw SystemGS Medical Co., Ltd.2006181—
+1K0504714CIS Solar Spine System and 4CIS Apollon Spine SystemSolco Biomedical Co., Ltd.2005127—
+1K043578The 4CIS Spinal System and 4CIS Low Back SystemSolco Biomedical Co., Ltd.2005125—
+1K042928Modification to Global Spinal Fixation SystemU&I Corp.2005124—
+1K033090Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc.20041801
+1K031455Conklusion Pedicle Screw SystemSignus Medical, LLC2003179—
+2K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+2K212700Dyflex-IITaeyeon Medical Co., Ltd.20220—
+2K2024984CIS SARA Spine System, 4CIS VERTU Spine SystemSolco Biomedical Company India Private Limited20213—
+2K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+2K181995Chiral Surgical Pedicle Screw SystemChiral Surgical20180—
+2K172546AnyPlus® Spinal Fixation SystemGS Medical Co., Ltd.201712—
+2K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.20164—
+2K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+2K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+2K150417Astra Spine SystemSpinecraft, LLC201521—
+2K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+2K130073Mikron Spinal Fixation System, Polyxial Pedicle Screws, Set Screws, Longitudinal RodsMikron Makina Sanayi VE Ticaret Ltd. Sti.20135—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+2K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+2K123476Mega 5.5 Spine SystemLsk Biopartners, Inc.20135—
+2K121568Dali Spinal Fixation SystemAccel Spine20121—
+2K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+2K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+2K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+2K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+2K110906Apex Spine SystemSpinecraft, LLC2011103—
+2K102574Palla M Spinal SystemKorea Bone Bank Co., Ltd.20112—
+2K1018184CIS Vane Spine SystemSolco Biomedical Co., Ltd.20112—
+2K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+2K100765Fixpine II SystemDio Medical Co., Ltd.201023—
+2K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2010168—
+2K092076Aegis & Aegis II Spinal SystemCorentec Co., Ltd.20103—
+2K092825Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw WasherSpinecraft, Inc.2010178—
+2K100138Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20100—
+2K091717Any Plus Spinal Fixation SystemGS Medical Co., Ltd.2010130—
+2K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2009170—
+2K092011Norm Spinal SystemNorm Tibbi Urunler Ithalat Ihracat Sanayi VE Ticar20090—
+2K083077Ulc Spinal Pedicle Screw SystemOtis Biotech Co., Ltd.20090—
+2K091189Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20093—
+2K090779Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20090—
+2K082509Eos Spinal SystemKorea Bone Bank Co., Ltd.2008140—
+2K0824534CIS Solar and Apollon Spine SystemsSolco Biomedical Co., Ltd.2008126—
+2K081108Monopoly Pedicle Screw SystemSignus Medical, LLC20080—
+2K081158Zodic Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20080—
+2K080876DVX Spine SystemBk Meditech, Co., Ltd.20081—
+2K070933Lowtop Pedicle Screw SystemSanacor2007178—
+2K051286Zodiac Spinal Fixation SystemAlphatec/Nexmed2005176—
+3K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+3K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+3K243073AnyPlus Navigated Instruments SystemGS Medical Co., Ltd.20240—
+3K240350AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd.20240—
+3K2326074CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle…Solco Biomedical Copany India Private Limited20240—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+3K231737ANAX™ 5.5 Spinal SystemInnosys Co., Ltd.20231—
+3K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+3K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+3K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K222415Rexious Spinal Fixation SystemDio Medical Corporation20221—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+3K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+3K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+3K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+3K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+3K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd.20174—
+3K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+3K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+3K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemGpc Medical Limited20170—
+3K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+3K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+3K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+3K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+3K143110GALAXY MIS Screw SystemBm Korea20152—
+3K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+3K143417ANAX 5.5 Spinal SystemU&I Corporation20154—