510(k) Report

Devices descending from K980288

959 later devices reach Spine-Tech Silhouette Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+1K042702Silhouette Spinal Fixation SystemZimmer Spine, Inc.20044—
+1K031511Dynesys Spinal SystemCenterpulse Spine-Tech, Inc.20049024
+1K022374Cadence Spinal Fixation SystemSulzer Spine-Tech2002841
+1K020196Modification to Silhouette Spinal Fixation SystemSulzer Spine-Tech20020—
+1K012173Device Modification of Silhouette Spindal Fixation SystemSulzer Spine-Tech20010—
+1K992276Modification to Silhouette Spinal Fixation SystemSulzer Spine-Tech1999171—
+2K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+2K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+2K133291ST360 Degrees Spinal Fixation SystemZimmer Spine, Inc.20131—
+2K111301Instinct Java SystemZimmer Spine201131
+2K073439Transition Stabilization SystemGlobus Medical, Inc.20092—
+2K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+2K071879Zimmer Dto ImplantZimmer Spine, Inc.200711
+2K072183ST360 Spinal Fixation System, Model 07.0029-7500.5600Zimmer Spine, Inc.200727—
+2K061774Nfix II Pedicle Screw SystemN Spine, Inc.200627
+2K061162Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc.2006131—
+2K060638Dynesys Spinal System with HA Coated ScrewsZimmer Spine, Inc.2006131
+2K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005870—
+2K043565Modification to Dynesys Spinal SystemZimmer Spine, Inc.20058341
+2K041925ST360 Spinal Fixation SystemZimmer Spine, Inc.2004831
+2K993067Silhouette Spinal Fixation SystemSulzer Spine-Tech1999111—
+3K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+3K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+3K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System…Zimmer Spine, Inc.20150—
+3K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+3K123552Instinct Java SystemZimmer Spine201301
+3K122592Instinct Java SystemZimmer Spine201301
+3K112684Mont Blanc Pedicle Screw SystemsQualgenix20125—
+3K113270Instinct Java SystemZimmer Spine201121
+3K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology201110—
+3K101704Zimmer Dto Pin Press InstrumentZimmer Spine, Inc.20100—
+3K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc.20091301
+3K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20096561
+3K080241DDS Stabilization SystemParadigm Spine, LLC20085—
+3K082236CD Horizon Spinal SystemMedtronic Sofamor Danek2008779—
+3K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+3K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+3K072022Valeo Pedicle Screw Spinal SystemAmedica Corp.2007100—
+3K072685Ngarde SystemN Spine, Inc.200709
+3K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek2007821—
+3K070245Capsure Pedicle Screw SystemSpine Wave, Inc.200742—
+3K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+3K060615CD Horizon Spinal SystemMedtronic Sofamor Danek200682234
+3K061915CD Horizon Spinal SystemMedtronic Sofamor Danek200654—
+3K052747Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek2005528—
+3K052609Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek200554—
+3K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005780—
+3K051674CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005587—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K221244CD Horizon™ Spinal SystemMedtronic202220—
+4K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+4K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+4K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+4K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+4K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+4K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+4K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+4K151977icotec Pedicle SystemIcotec AG201630—
+4K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+4K150185Mont Blanc Spinal SystemSpineway20154—
+4K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+4K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+4K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+4K142591CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2014212—
+4K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+4K141044M.U.S.T. ExtensionMedacta International201416—
+4K141494CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014273—
+4K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+4K132878M.U.S.T. ExtensionMedacta International201328—
+4K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+4K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+4K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+4K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+4K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+4K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+4K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc.201371
+4K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+4K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix2012116—
+4K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+4K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+4K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+4K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+4K120491DSS Stabilization System-RigidParadigm Spine, LLC20120—
+4K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+4K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+4K113625DSS Stabilization SystemParadigm Spine, LLC20121—
+4K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+4K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011597—
+4K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597—
+4K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+4K111571Viper SystemsJohnson & Johnson2011203—
+4K111183Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods)Orthofix, Inc.201122—
+4K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc.20119—