FDA 510(k) Applications Submitted by Globus Medical, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K131449 |
05/20/2013 |
COALITION SPACER |
GLOBUS MEDICAL, INC. |
| K132191 |
07/15/2013 |
SP-FIX SPINOUS PROCESS FIXATION PLATE |
GLOBUS MEDICAL, INC. |
| K133350 |
10/30/2013 |
REVERE STABILIZATION SYSTEM |
GLOBUS MEDICAL, INC. |
| K133482 |
11/13/2013 |
SILC FIXATION SYSTEM |
GLOBUS MEDICAL, INC. |
| K133678 |
11/29/2013 |
CONFIRM BIOACTIVE |
GLOBUS MEDICAL, INC. |
| K240568 |
02/29/2024 |
DuraProÖ Oscillating System |
Globus Medical, Inc. |
| K201087 |
04/23/2020 |
CORBEL Spacers |
Globus Medical, Inc. |
| K241525 |
05/30/2024 |
ExcelsiusXRÖ |
Globus Medical, Inc. |
| K222409 |
08/10/2022 |
CAPTIVATE« Compression Screws |
Globus Medical, Inc. |
| K233638 |
11/13/2023 |
VERZAÖ High Speed Drills |
Globus Medical, Inc. |
| K243671 |
11/27/2024 |
ExcelsiusGPS« Instruments |
Globus Medical, Inc. |
| K234035 |
12/20/2023 |
COSINEÖ Spacer |
Globus Medical, Inc. |
| K082252 |
08/08/2008 |
INDEPENDENCE SPACER |
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. |
| K080664 |
03/10/2008 |
RELIEVE LAMINOPLASTY FIXATION SYSTEM |
GLOBUS MEDICAL, INC. |
| K040721 |
03/19/2004 |
ASSURE ANTERIOR CERVICAL PLATE SYSTEM |
GLOBUS MEDICAL, INC. |
| K090952 |
04/03/2009 |
ZYFUSE FACET FIXATION SYSTEM |
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. |
| 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. |
| K102195 |
08/04/2010 |
SP-FIX SPINOUS PROCESS FIXATION PLATE |
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. |
| 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. |
| K083416 |
11/18/2008 |
REVOLVE STABILIZATION SYSTEM |
GLOBUS MEDICAL, INC. |
| K083442 |
11/20/2008 |
CORRIDOR FIXATION SYSTEM |
GLOBUS MEDICAL, INC. |
| K113447 |
11/21/2011 |
RISE SPACER |
GLOBUS MEDICAL, INC. |
| K073517 |
12/14/2007 |
H-LINK INTEGRATED ROD |
GLOBUS MEDICAL, INC. |
| K161379 |
05/18/2016 |
ELSA Spacers |
GLOBUS MEDICAL, INC. |
| K191835 |
07/09/2019 |
CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments |
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. |
| K162618 |
09/20/2016 |
CONCORD Plus Radiopaque Bone Cement |
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. |
| K171939 |
06/28/2017 |
ALVUE Balloon Dilation System |
Globus Medical, Inc. |
| K122097 |
07/16/2012 |
PATRIOT SPACERS |
GLOBUS MEDICAL, INC. |
| K121107 |
04/12/2012 |
FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R) |
GLOBUS MEDICAL, INC. |
| K123783 |
12/10/2012 |
ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS |
GLOBUS MEDICAL, INC. |
| K130478 |
02/25/2013 |
SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS |
GLOBUS MEDICAL, INC. |
| K111449 |
05/25/2011 |
REVOLVE ADDITIONAL IMPLANTS |
GLOBUS MEDICAL, INC. |
| K112028 |
07/15/2011 |
SI-LOK SACROILIAC JOINT FIXATION SYSTEM |
GLOBUS MEDICAL, INC. |
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