510(k) Report

Devices descending from K953599

252 later devices reach Clamp Assembly through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K980484Aesculap Spine System EvolutionAesculap, Inc.1998251—
+2K001080Spine System EvolutionAesculap, Inc.200062—
+2K990118Isobar Spinal SystemScien'Tx USA, Inc.1999250—
+3K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+3K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+3K113755Savannah Technologies Spinal SystemSavannah Technologies, LLC20120—
+3K103573ARTS2 Spinal Fixation SystemAdvanced Medical Technologies20110—
+3K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+3K110321Tiger Spine SystemCorelink, LLC201183—
+3K062912Scient'x Spinal SystemScient'X200736—
+3K061774Nfix II Pedicle Screw SystemN Spine, Inc.200627
+3K061162Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc.2006131—
+3K051063Polyaxial Hemispherical Spinal ScrewsScient'X200537—
+3K040747Aladyn Rigid Spine PlateScient'X20040—
+3K033150Art Posterior Spinal SystemAdvanced Medical Technologies AG20041—
+3K020245Modification to Isobar Spinal SystemScien'Tx USA, Inc.200243—
+3K013444Isobar Spinal SystemScien'Tx USA, Inc.200194—
+3K991326Isobar Semi-Rigid Spinal SystemScien'Tx USA, Inc.19992—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+4K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+4K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+4K133369Tiger Spine SystemCorelink, LLC201429—
+4K131250Tiger Spine SystemCorelink, LLC201340—
+4K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+4K120838Synthes Matrix SystemSynthes Spine201216—
+4K120696Tiger Spine SystemCorelink, LLC201241—
+4K113058Tiger Spine SystemCorelink, LLC201281—
+4K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc.20091301
+4K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+4K072685Ngarde SystemN Spine, Inc.200709
+4K043001MX Polyaxial Pedicle ScrewScient'X200437—
+4K042964MX Monoaxial Pedicle ScrewScient'X200438—
+4K042953Modification to Protex Stabilization SystemGlobus Medical, Inc.20040—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+5K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+5K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+5K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+5K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+5K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+5K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+5K193219G Surgical Marksman SystemG Surgical, LLC20191—
+5K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+5K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+5K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+5K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+5K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+5K180433Ennovate®Aesculap Implant Systems, LLC201811
+5K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemGpc Medical Limited20170—
+5K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+5K153404Zavation Spinal SystemZavation, LLC20161—
+5K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+5K151977icotec Pedicle SystemIcotec AG201630—
+5K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+5K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+5K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+5K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+5K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+5K141850Flospine Pedicle Screw SystemFlospine20140—
+5K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+5K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+5K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix2012116—
+5K111183Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods)Orthofix, Inc.201122—
+5K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+5K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone2010117—
+6K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+6K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+6K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+6K222789VADER® Pedicle System, G21 CementIcotec AG202352
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—