FDA 510(k) Applications Submitted by CHRISTINA L KICHULA
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K140411 |
02/18/2014 |
ALTERA SPACER |
GLOBUS MEDICAL INC. |
| K000820 |
03/13/2000 |
AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700 |
ENDOSONICS CORP. |
| K020854 |
03/15/2002 |
MODIFICATION TO FOX PTA CATHETER |
JOMED AG |
| K131449 |
05/20/2013 |
COALITION SPACER |
GLOBUS MEDICAL, INC. |
| K132191 |
07/15/2013 |
SP-FIX SPINOUS PROCESS FIXATION PLATE |
GLOBUS MEDICAL, INC. |
| K132559 |
08/15/2013 |
MONUMENT SPACERS |
GLOBUS MEDICAL INC. |
| K123231 |
10/16/2012 |
CALIBER SPACERS |
GLOBUS MEDICAL INC. |
| K133350 |
10/30/2013 |
REVERE STABILIZATION SYSTEM |
GLOBUS MEDICAL, INC. |
| K043139 |
11/12/2004 |
USCOM 1A |
USCOM, LTD. |
| K133482 |
11/13/2013 |
SILC FIXATION SYSTEM |
GLOBUS MEDICAL, INC. |
| K133567 |
11/20/2013 |
UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM |
GLOBUS MEDICAL INC. |
| K133678 |
11/29/2013 |
CONFIRM BIOACTIVE |
GLOBUS MEDICAL, INC. |
| K123913 |
12/19/2012 |
LATIS SPACER |
GLOBUS MEDICAL INC. |
| K003938 |
12/20/2000 |
TRAK BACK II |
JOMED, INC. |
| K070961 |
04/05/2007 |
BIOMERIX SURGICAL MESH, MODEL: RCR-01 |
BIOMERIX CORPORATION |
| K112499 |
08/30/2011 |
BIOMERIX COMPOSITE SURGICAL MESH |
BIOMERIX CORPORATION |
| K112567 |
09/02/2011 |
BIOMERIX ASSURE |
BIOMERIX CORPORATION |
| K082941 |
10/02/2008 |
BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215 |
BIOMERIX CORPORATION |
| K093123 |
10/02/2009 |
BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB |
BIOMERIX CORPORATION |
| K043371 |
12/08/2004 |
BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER |
BIOMERIX CORPORATION |
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