FDA 510(k) Applications Submitted by GLOBUS MEDICAL INC.

FDA 510(k) Number Submission Date Device Name Applicant
K140411 02/18/2014 ALTERA SPACER GLOBUS MEDICAL INC.
K132559 08/15/2013 MONUMENT SPACERS GLOBUS MEDICAL INC.
K123231 10/16/2012 CALIBER SPACERS GLOBUS MEDICAL INC.
K133567 11/20/2013 UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM GLOBUS MEDICAL INC.
K123913 12/19/2012 LATIS SPACER GLOBUS MEDICAL INC.
K031302 04/24/2003 SUSTAIN SPACER GLOBUS MEDICAL INC.
K200047 01/09/2020 ExcelsiusGPS Cranial 1.0 Module Globus Medical Inc.
K230565 03/01/2023 HILINEÖ Fixation System Globus Medical Inc.
K220659 03/07/2022 AUTOBAHN(R) EVO Femoral Nails Globus Medical Inc.
K231333 05/08/2023 STRETTOÖ Cable System Globus Medical Inc.
K221737 06/15/2022 InstaFill Graft Delivery System, SIGNIFY Bioactive Globus Medical Inc.
K211957 06/24/2021 QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments Globus Medical Inc.
K201733 06/25/2020 Provident II Hip Stems Globus Medical Inc.
K212433 08/04/2021 Anthem Fracture System Globus Medical Inc.
K202496 08/31/2020 ANTHEM Fracture System Globus Medical Inc.
K203153 10/22/2020 CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Globus Medical Inc.
K213591 11/12/2021 ANTHEM« Fracture System Globus Medical Inc.
K213842 12/09/2021 ONVOY Acetabular System Globus Medical Inc.
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.
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.
K090565 03/02/2009 ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM GLOBUS MEDICAL INC.
K060665 03/14/2006 XPAND RADIOLUCENT CORPECTOMY SPACER GLOBUS MEDICAL INC.
K070775 03/21/2007 MODIFICATION TO: PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEM GLOBUS MEDICAL INC.
K050850 04/04/2005 XPAND CORPECTOMY SPACER GLOBUS MEDICAL INC.
K081195 04/28/2008 REVERE UNIPLANAR SCREWS 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.
K052069 08/01/2005 PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES GLOBUS MEDICAL INC.
K102293 08/13/2010 CALIBER SPACER 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.
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.
K103382 11/18/2010 INTERCONTINENTAL PLATE-SPACER GLOBUS MEDICAL INC.
K073439 12/07/2007 TRANSITION STABILIZATION SYSTEM 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.
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.
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.
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.
K173115 09/29/2017 COALITION« and COALITION« TPS, COALITION MIS« and COALITION MIS« TPS, COALITION AGX« and COALITION AGX« TPS Globus Medical Inc.
K173166 09/29/2017 ANTHEM Fracture System Globus Medical Inc.
K213196 09/29/2021 MARVELÖ Growing Rods Globus Medical Inc.
K192744 09/30/2019 CORRIDOR Fixation System Globus Medical Inc.
K163361 11/30/2016 ANTHEMÖ Fracture System Globus Medical Inc.
K143633 12/22/2014 CREO Stabilization System GLOBUS MEDICAL INC.
K180156 01/19/2018 SP-Fix« Spinous Process Fixation Plate, RELIEVE« Laminoplasty Fixation System Globus Medical Inc.
K180690 03/16/2018 Navigation Instruments Globus Medical Inc.
K171848 06/21/2017 FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS Globus Medical Inc.
K181846 07/11/2018 ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolu Globus Medical Inc.
K172417 08/10/2017 SILC« Fixation System Globus Medical Inc.
K183119 11/09/2018 SI-LOK« Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS« Instruments Globus Medical Inc.
K173982 12/29/2017 FORTIFY Corpectomy Spacers Globus Medical Inc.
K120101 01/12/2012 INDEPENDENCE SPACER GLOBUS MEDICAL INC.
K121049 04/06/2012 UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM GLOBUS MEDICAL INC.
K121922 07/02/2012 BEACON STABILIZATION SYSTEM GLOBUS MEDICAL INC.
K122226 07/26/2012 REVERE STABILIZATION SYSTEM GLOBUS MEDICAL INC.
K121732 06/13/2012 CANOPY LAMINOPLASTY FIXATION SYSTEM GLOBUS MEDICAL INC.
K120092 01/11/2012 PLYMOUTH THORACOLUMBAR PLATE SYSTEM GLOBUS MEDICAL INC.
K111479 05/27/2011 REVERE CROSSTOP GLOBUS MEDICAL INC.
K113395 11/17/2011 REVERE 4.5 STABILIZATION SYSTEM GLOBUS MEDICAL INC.
K124058 12/31/2012 CREO STABILIZATION SYSTEM GLOBUS MEDICAL INC.
K130392 02/15/2013 KINEX BIOACTIVE GLOBUS MEDICAL INC.
K130977 04/09/2013 SIGNIFY BIOACTIVE GLOBUS MEDICAL INC.


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