510(k) Report

Devices descending from K940631

559 later devices reach Cross Medical - Synergy (TM) Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+1K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+1K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+1K150417Astra Spine SystemSpinecraft, LLC201521—
+1K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+1K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+1K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+1K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+1K100438Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation SystemEbi, L.P.2010104—
+1K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+1K071377Polaris BE RodsBiomet Spine20070—
+1K012871Synergy TI Integral Open Screws Models # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176…Interpore Cross Intl.200111—
+1K982914Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc.1998251—
+1K980484Aesculap Spine System EvolutionAesculap, Inc.1998251—
+1K974749Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior…Cross Medical Products, Inc.1998311—
+1K973836Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy…Cross Medical Products, Inc.1998529—
+2K241663Eminent Spine 3D Titanium Pedicle Screw SystemEminent Spine20250—
+2K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+2K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+2K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+2K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+2K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+2K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+2K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+2K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+2K223273ASTRA Spine SystemSpinecraft, LLC20228—
+2K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+2K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+2K211323ASTRA Spine SystemSpinecraft, LLC202112—
+2K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+2K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+2K190567KeYi Spinal Fixation SystemBeijing Keyi Medical Device Technology Co., Ltd.20190—
+2K181995Chiral Surgical Pedicle Screw SystemChiral Surgical20180—
+2K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+2K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+2K162786PASS LP Spinal SystemMedicrea International SA20176—
+2K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+2K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+2K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+2K133690True Spinal Fussion SystemInnovative Surgical Designs20140—
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+2K133103Aversion Pedicle Screw SystemK7, LLC20140—
+2K130958True Spinal Fixation SystemInnovative Surgical Designs20131—
+2K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+2K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+2K112684Mont Blanc Pedicle Screw SystemsQualgenix20125—
+2K120074Foundation Spinal SystemThe Skeletal Design Partnership, Ltd.20122—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+2K113173Nanovis Spinal SystemNanovis, LLC20122—
+2K110046Athena Pedicle Screw SystemRoyal Oak Medical Devices20110—
+2K112493Pass LP Spinal SystemMedicrea International20111—
+2K111883Smartloc Spinal Fixation SystemA-Spine Asia, Co., Ltd.20112—
+2K110906Apex Spine SystemSpinecraft, LLC2011103—
+2K102853Flamenco Spinal Fixation SystemUlrich GmbH & Co. KG2011221
+2K101278Inertia Pedicle Screw SystemNexxt Spine, LLC2010111—
+2K093833Kapss Spinal SystemRobert Reid, Inc.20100—
+2K100377Diamondback Spinal SystemEminent Spine201029—
+2K080241DDS Stabilization SystemParadigm Spine, LLC20085—
+2K081108Monopoly Pedicle Screw SystemSignus Medical, LLC20080—
+2K072022Valeo Pedicle Screw Spinal SystemAmedica Corp.2007100—
+2K071921Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial…Innovasis, Inc.20075—
+2K051704Mykres Spinal SystemShowa Ika Kohgyo Co., Ltd.20066—
+2K042143Excella-M Spinal SystemInnovasis, Inc.20046—
+2K001080Spine System EvolutionAesculap, Inc.200062—
+2K993503Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc.2000176—
+2K990118Isobar Spinal SystemScien'Tx USA, Inc.1999250—
+2K983353SCS Spinal SystemOrthotec, Inc.19982—
+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—
+3K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+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—
+3K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+3K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+3K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+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—
+3K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+3K182240PASS LP Spinal SystemMedicrea International SA20182—
+3K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+3K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+3K180324Patriot Spinal Fixation SystemValorus Spine20180—
+3K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+3K173126Arisstos™ Spinal SystemIngenium Spine20171—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K153413PASS LP Spinal SystemMedicrea International SA20160—
+3K151977icotec Pedicle SystemIcotec AG201630—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—