FDA 510(k) Applications Submitted by Kelly J Baker

FDA 510(k) Number Submission Date Device Name Applicant
K100788 03/22/2010 COCR RODS GLOBUS MEDICAL INC.
K210912 03/29/2021 Excelsius3D Globus Medical Inc.
K061202 05/01/2006 REVERE STABILIZATION SYSTEM GLOBUS MEDICAL INC.
K191243 05/09/2019 HEDRON Cervical Spacers Globus Medical Inc.
K181357 05/22/2018 PATRIOT« Lumbar Spacers, SUSTAIN« Spacers Globus Medical Inc.
K191391 05/24/2019 HEDRON Lumbar Spacers Globus Medical Inc.
K211616 05/26/2021 ExcelsiusHub Globus Medical Inc.
K221894 06/30/2022 Lumbar Expandable lnterbody Spacers -Additional Indications/Implants Globus Medical Inc.
K222270 07/29/2022 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments Globus Medical Inc.
K082252 08/08/2008 INDEPENDENCE SPACER GLOBUS MEDICAL, INC.
K142218 08/12/2014 Coalition AGX Plate and Coalition AGX Spacer GLOBUS MEDICAL INC.
K203278 11/06/2020 INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers Globus Medical Inc.
K173722 12/05/2017 PATRIOT COLONIAL Spacer, SUSTAIN Spacer Globus Medical Inc.
K160597 03/02/2016 INDEPENDENCE MIS Spacers GLOBUS MEDICAL INC.
K110280 01/31/2011 REVLOK FENESTRATED SCREW SYSTEM GLOBUS MEDICAL INC.
K040284 02/06/2004 SUSTAIN RADIOLUCENT SPACER GLOBUS MEDICAL, INC.
K050391 02/16/2005 PROTEX CT CERVICOTHORACIC SPINAL SYSTEM GLOBUS MEDICAL, INC.
K040442 02/20/2004 PROTEX STABILIZATION SYSTEM GLOBUS MEDICAL, INC.
K090565 03/02/2009 ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM GLOBUS MEDICAL INC.
K080664 03/10/2008 RELIEVE LAMINOPLASTY FIXATION SYSTEM GLOBUS MEDICAL, INC.
K060665 03/14/2006 XPAND RADIOLUCENT CORPECTOMY SPACER GLOBUS MEDICAL INC.
K040721 03/19/2004 ASSURE ANTERIOR CERVICAL PLATE SYSTEM GLOBUS MEDICAL, INC.
K070775 03/21/2007 MODIFICATION TO: PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEM GLOBUS MEDICAL INC.
K090952 04/03/2009 ZYFUSE FACET FIXATION SYSTEM GLOBUS MEDICAL, INC.
K050850 04/04/2005 XPAND CORPECTOMY SPACER GLOBUS MEDICAL INC.
K110998 04/11/2011 AFFIRM (TM) VCF SYSTEM ALGEA THERAPIES
K081195 04/28/2008 REVERE UNIPLANAR SCREWS GLOBUS MEDICAL INC.
K071187 04/30/2007 MICROFUSE BONE VOID FILLER GLOBUS MEDICAL, INC.
K061380 05/18/2006 RETAIN RADIOLUCENT SPACER GLOBUS MEDICAL, INC.
K081391 05/19/2008 VIP ANTERIOR CERVICAL PLATE SYSTEM GLOBUS MEDICAL, INC.
K091782 06/17/2009 REVERE 6.35 STABILIZATION SYSTEM GLOBUS MEDICAL INC.
K151665 06/19/2015 SUSTAIN Additional Implants GLOBUS MEDICAL INC.
K081906 07/03/2008 PROTEX CT CERVICOTHORACIC SPINAL SYSTEM GLOBUS MEDICAL, INC.
K092108 07/14/2009 TRUSS THORACOLUMBAR PLATE SYSTEM GLOBUS MEDICAL, INC.
K092146 07/15/2009 XTEND ANTERIOR CERVICAL PLATE SYSTEM GLOBUS MEDICAL, INC.
K052069 08/01/2005 PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES GLOBUS MEDICAL INC.
K102195 08/04/2010 SP-FIX SPINOUS PROCESS FIXATION PLATE GLOBUS MEDICAL, INC.
K042168 08/09/2004 CONCORD Radiopaque Bone Cement Globus Medical, Inc
K102293 08/13/2010 CALIBER SPACER GLOBUS MEDICAL INC.
K102313 08/16/2010 PATRIOT TRANSCONTINENTAL M SPACERS GLOBUS MEDICAL, INC.
K062407 08/17/2006 GATEWAY THORACOLUMBAR PLATE SYSTEM GLOBUS MEDICAL, INC.
K082442 08/25/2008 MODIFICATION TO MICROFUSE BONE VOID FILLER GLOBUS MEDICAL, INC.
K092610 08/25/2009 MODIFICATION TO BEACON STABILIZATION SYSTEM GLOBUS MEDICAL, INC.
K192314 08/26/2019 RESONATE Anterior Cervical Plate System Globus Medical Inc.
K072465 09/04/2007 NIKO CORPECTOMY SPACER GLOBUS MEDICAL INC.
K142498 09/05/2014 MAGNIFY and MAGNIFY-S Spacers GLOBUS MEDICAL INC.
K062836 09/20/2006 CITADEL ANTERIOR LUMBAR PLATE SYSTEM GLOBUS MEDICAL INC.
K112756 09/21/2011 FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS GLOBUS MEDICAL, INC.
K093242 10/15/2009 PATRIOT TRANSCONTINENTAL LLIF SPACER GLOBUS MEDICAL, INC.
K103072 10/18/2010 REVERE SACRAL PLATES GLOBUS MEDICAL, INC.
K072970 10/22/2007 PATRIOT SPACERS GLOBUS MEDICAL, INC.
K072991 10/23/2007 PATRIOT SPACERS: COLONIAL ACDF GLOBUS MEDICAL, INC.
K042953 10/26/2004 MODIFICATION TO PROTEX STABILIZATION SYSTEM GLOBUS MEDICAL, INC.
K083232 11/03/2008 MODIFICATION TO:MICROFUSE BONE VOID FILLER GLOBUS MEDICAL INC.
K153203 11/04/2015 Navigation Instruments GLOBUS MEDICAL INC.
K073172 11/13/2007 BEACON STABILIZATION SYSTEM GLOBUS MEDICAL INC.
K083389 11/17/2008 COALITION SPACER GLOBUS MEDICAL INC.
K083416 11/18/2008 REVOLVE STABILIZATION SYSTEM GLOBUS MEDICAL, INC.
K103382 11/18/2010 INTERCONTINENTAL PLATE-SPACER GLOBUS MEDICAL INC.
K083442 11/20/2008 CORRIDOR FIXATION SYSTEM GLOBUS MEDICAL, INC.
K113447 11/21/2011 RISE SPACER GLOBUS MEDICAL, INC.
K073439 12/07/2007 TRANSITION STABILIZATION SYSTEM GLOBUS MEDICAL INC.
K073517 12/14/2007 H-LINK INTEGRATED ROD GLOBUS MEDICAL, INC.
K143578 12/17/2014 SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer GLOBUS MEDICAL INC.
K102392 08/23/2010 MICROFUSE PUTTY AND MICROFUSE ST MIS GLOBUS MEDICAL INC.
K110963 04/06/2011 ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM GLOBUS MEDICAL INC.
K093294 10/21/2009 REVERE STABILIZATION SYSTEM GLOBUS MEDICAL INC.
K170157 01/18/2017 INDEPENDENCE« Spacers Globus Medical Inc.
K180210 01/24/2018 CREO« Stabilization System Globus Medical Inc.
K190147 01/29/2019 COLOSSEUM Mesh Globus Medical Inc.
K180554 03/01/2018 ANTHEM Fracture System Globus Medical Inc.
K150552 03/04/2015 ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS GLOBUS MEDICAL INC.
K190598 03/07/2019 CROSSWAY Spinal Access System Globus Medical Inc.
K190653 03/14/2019 ExcelsiusGPS Globus Medical Inc.
K180817 03/29/2018 AERIALÖ Interspinous Fixation Globus Medical Inc.
K180909 04/06/2018 REVEL Spacers Globus Medical Inc.
K171108 04/14/2017 AUTOBAHN Nailing System Globus Medical Inc.
K181068 04/23/2018 CREO« Stabilization System, REVERE« Stabilization System Globus Medical Inc.
K191100 04/25/2019 ExcelsiusGPS Spine 1.1 Interbody Module Globus Medical Inc.
K161223 04/29/2016 TransContinental« M Spacers and InterContinental« Plate-Spacers GLOBUS MEDICAL INC.
K171413 05/15/2017 HAVENÖ Laminoplasty System, CANOPY« Laminoplasty Fixation System Globus Medical Inc.
K161379 05/18/2016 ELSA Spacers GLOBUS MEDICAL, INC.
K171651 06/05/2017 EXCELSIUS GPS Globus Medical Inc.
K161591 06/09/2016 QUARTEXÖ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments GLOBUS MEDICAL INC.
K191835 07/09/2019 CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments Globus Medical, Inc.
K151939 07/14/2015 COALITION Spacers GLOBUS MEDICAL INC.
K152022 07/21/2015 SUSTAIN« R Spacers, PATRIOT« Spacers, CALIBER« Spacers, RISE« Spacers, COALITION« Spacers, COALITION AGXÖ Spacers, INDEPENDENCE« Spacers, FORTIFY«-R Corpectomy Spacers, FORTIFY« I-R Corpectomy Spacers, XPand«-R Corpectomy Spacers, NIKO« Corpectomy Spacers GLOBUS MEDICAL INC.
K182000 07/26/2018 AQrate Robotic Assistance System Globus Medical Inc.
K172269 07/28/2017 FORTRESSÖ Radiopaque Bone Cement (FORTRESSÖ and FORTRESS-PlusÖ), CREO« Fenestrated Screw System, REVLOK« Fenestrated Screw System Globus Medical, Inc.
K192115 08/06/2019 SABLE Expandable Spacer Globus Medical Inc.
K172438 08/11/2017 ARBOR External Fixation System Globus Medical Inc.
K162315 08/18/2016 FORTIFY Corpectomy Spacers GLOBUS MEDICAL INC.
K182375 08/31/2018 CREO« Stabilization System, Navigation Instruments, ExcelsiusGPS« Globus Medical Inc.
K162618 09/20/2016 CONCORD Plus Radiopaque Bone Cement GLOBUS MEDICAL, INC.
K173166 09/29/2017 ANTHEM Fracture System Globus Medical Inc.
K173115 09/29/2017 COALITION« and COALITION« TPS, COALITION MIS« and COALITION MIS« TPS, COALITION AGX« and COALITION AGX« TPS Globus Medical Inc.
K213196 09/29/2021 MARVELÖ Growing Rods Globus Medical Inc.
K192744 09/30/2019 CORRIDOR Fixation System Globus Medical Inc.
K162825 10/07/2016 CAPTIVATEÖ Compression Screws GLOBUS MEDICAL, INC.
K183056 11/02/2018 ASSURE« Anterior Cervical Plate System Globus Medical, Inc.
K163361 11/30/2016 ANTHEMÖ Fracture System Globus Medical Inc.
K143633 12/22/2014 CREO Stabilization System GLOBUS MEDICAL INC.


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