FDA 510(k) Applications Submitted by LORI A BURNS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| 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. |
| K171939 |
06/28/2017 |
ALVUE Balloon Dilation System |
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. |
| K103787 |
12/27/2010 |
MEDEOR MATRIX |
KENSEY NASH CORP. |
| K143716 |
12/29/2014 |
DSM Biomedical DPR Cable |
DSM BIOMEDICAL |
| K173982 |
12/29/2017 |
FORTIFY Corpectomy Spacers |
Globus Medical Inc. |
| K121310 |
05/01/2012 |
MESOTHELIUM DENTAL MEMBRANE |
KENSEY NASH CORPORATION |
| K112888 |
09/30/2011 |
MESO WOUND MATRIX |
KENSEY NASH CORPORATION |
| K094061 |
12/31/2009 |
KENSEY NASH ECM SURGICAL PATCH |
KENSEY NASH CORPORATION |
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