510(k) Report

Devices descending from K002059

696 later devices reach Amt Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083178Solas Anatomix Spinal SystemBiotechni America Spine Group, Inc.20090—
+1K031585U&I, Optima, Spinal SystemU&I Corp., America20035795
+1K024096Optima, Spinal SystemU&I Corp., America20034663
+1K022768Amt Polyaxial Pedicle ScrewMicron Precision Engineering, Inc.20020—
+1K020279Forex Corporation, Optima, Spinal SystemForex Corp.20026934
+2K231737ANAX™ 5.5 Spinal SystemInnosys Co., Ltd.20231—
+2K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+2K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+2K153404Zavation Spinal SystemZavation, LLC20161—
+2K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+2K151849Seneka I Polyscrew Pedicle Fixation SystemSenecka Spine20151—
+2K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+2K143417ANAX 5.5 Spinal SystemU&I Corporation20154—
+2K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+2K141850Flospine Pedicle Screw SystemFlospine20140—
+2K141044M.U.S.T. ExtensionMedacta International201416—
+2K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+2K133066Spineselect Polyscrew Pedicle Screw SystemSpineselect, LLC20140—
+2K132218Perfix Iliac Screw SystemU&I Corporation20130—
+2K130073Mikron Spinal Fixation System, Polyxial Pedicle Screws, Set Screws, Longitudinal RodsMikron Makina Sanayi VE Ticaret Ltd. Sti.20135—
+2K132101Anax 5.5 Spinal SystemU&I Corporation201313—
+2K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+2K1216154CIS Vane Spine SystemSolco Biomedical Co., Ltd.20121—
+2K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+2K120353Synster Pedicle Screw System Synster Plus Pedicle Screw SystemBm Korea Co., Ltd.20123—
+2K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+2K113361Securis Spinal FixationCumtom Spine20120—
+2K111448Icon (TM) Modular Pedicle Screw SystemOrthofix, Inc.20120—
+2K113625DSS Stabilization SystemParadigm Spine, LLC20121—
+2K111995Xingtm Spine SystemImplanova Co., Ltd.20110—
+2K111883Smartloc Spinal Fixation SystemA-Spine Asia, Co., Ltd.20112—
+2K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc.201116—
+2K1024584CIS Solar Spine System and 4CIS Apollon Spine SystemSolco Biomedical Co., Ltd.20114—
+2K111099Issys LP Spinal Fixation SystemCustom Spine, Inc.201111
+2K1018184CIS Vane Spine SystemSolco Biomedical Co., Ltd.20112—
+2K103085Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd.2011123—
+2K102853Flamenco Spinal Fixation SystemUlrich GmbH & Co. KG2011221
+2K101278Inertia Pedicle Screw SystemNexxt Spine, LLC2010111—
+2K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+2K102331LDR Spine Usa Spinetune TL Spinal SystemLdr Spine USA20106—
+2K100706Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd.2010124—
+2K100956Spondy Spinal Fixation SystemAllure Spine LLC201017—
+2K100373Tyche Pedicle Screw SystemKyung Won Medical Co., Ltd.20104—
+2K093104Medyssey CO., LTD., Zenius Spinal SystemMedyssey Co, Ltd.201020—
+2K092076Aegis & Aegis II Spinal SystemCorentec Co., Ltd.20103—
+2K091725Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020 (Total: 549)U&I Corp.2009150—
+2K092011Norm Spinal SystemNorm Tibbi Urunler Ithalat Ihracat Sanayi VE Ticar20090—
+2K081145Modification to 4CIS Vane Spine SystemSolco Biomedical Co., Ltd.2008127—
+2K081108Monopoly Pedicle Screw SystemSignus Medical, LLC20080—
+2K072116Savannah Lumbar Percutaneous Stabilization SystemNeurospine Innovations and Solutions200824—
+2K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+2K072866Issys LP Spinal Fixation SystemCustom Spine, Inc.200721
+2K072022Valeo Pedicle Screw Spinal SystemAmedica Corp.2007100—
+2K072436Mega Spine SystemBk Meditech, Co., Ltd.20079—
+2K071879Zimmer Dto ImplantZimmer Spine, Inc.200711
+2K071438PSS SystemSpinal USA200739—
+2K071857Delta Spinal Fusion SystemJemo Spine, LLC2007109—
+2K070933Lowtop Pedicle Screw SystemSanacor2007178—
+2K0637084S Spinal SystemTaeyeon Medical Co., Ltd.20078—
+2K062785LTD Polyaxial Fixation SystemUs Spine200641—
+2K061774Nfix II Pedicle Screw SystemN Spine, Inc.200627
+2K051704Mykres Spinal SystemShowa Ika Kohgyo Co., Ltd.20066—
+2K0607024CIS Vane Spine SystemSolco Biomedical Co., Ltd.2006166—
+2K053573GSS Pedicle Screw SystemGS Medical Co., Ltd.2006181—
+2K053070Contour II Spinal SystemAltiva Corp.20060—
+2K051716Vertebron PSS Pedicle Screw SystemVertebron, Inc.200556—
+2K0504714CIS Solar Spine System and 4CIS Apollon Spine SystemSolco Biomedical Co., Ltd.2005127—
+2K043578The 4CIS Spinal System and 4CIS Low Back SystemSolco Biomedical Co., Ltd.2005125—
+2K043152Vertebron PSS Pedicle Screw SystemVertebron, Inc.200561—
+2K033090Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc.20041801
+3K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+3K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+3K252730Fule Spinal Fixation SystemBeijing Fule Science & Technology Development Co., Ltd.20250—
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+3K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K233960INNOVERSE Spinal SystemInnosys Co., Ltd.20240—
+3K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+3K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+3K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+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—
+3K212700Dyflex-IITaeyeon Medical Co., Ltd.20220—
+3K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+3K2024984CIS SARA Spine System, 4CIS VERTU Spine SystemSolco Biomedical Company India Private Limited20213—
+3K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+3K203452Nano FortiFix® SystemNanovis, LLC20200—
+3K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+3K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+3K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+3K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—