FDA 510(k) Applications Submitted by FRANK JURCZAK
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K090230 |
01/30/2009 |
EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
| K110551 |
02/28/2011 |
EXPEDIUM SPINE SYSTEM |
JOHNSON & JOHNSON |
| K090648 |
03/11/2009 |
VIPER 2 SYSTEM |
DEPUY SPINE, INC. |
| K090799 |
03/24/2009 |
MODIFICATION TO EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
| K111136 |
04/22/2011 |
EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM |
DEPUY SPINE, INC. |
| K101762 |
06/22/2010 |
VIPER F2 FACET FIXATION SYSTEM |
DEPUY SPINE, INC. |
| K101993 |
07/15/2010 |
VIPER SYSTEM, EXPEDIUM SYSTEM |
DEPUY SPINE, INC. |
| K082195 |
08/04/2008 |
MODIFICATIONS TO EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
| K082273 |
08/11/2008 |
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM |
DEPUY SPINE, INC. |
| K092626 |
08/27/2009 |
MODIFICATION TO: EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
| K082942 |
10/02/2008 |
MODFICATION TO: EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
| K143481 |
12/08/2014 |
IntellaMap Orion High Resolution Mapping Catheter |
RHYTHMIA MEDICAL, INC |
| K080191 |
01/25/2008 |
EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM |
DEPUY SPINE, INC. |
| K070994 |
04/09/2007 |
EAGLE + ANTERIOR CERVICAL PLATE SYSTEM |
DEPUY SPINE, INC. |
| K072546 |
09/10/2007 |
SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM |
DEPUY SPINE,INC |
| K103491 |
11/26/2010 |
SKYLINE ANTERIOR CERVICAL PLATE SYSTEM |
A JOHNSON & JOHNSON COMPANY |
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