FDA 510(k) Applications Submitted by FREDERIC TESTA
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K050118 |
01/18/2005 |
EBI TROCHANTERIC NAIL SYSTEM |
EBI, L.P. |
| K030372 |
02/04/2003 |
MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM |
EBI, L.P. |
| K040482 |
02/25/2004 |
EBI ESL SPINE SPACER SYSTEM |
EBI, L.P. |
| K030706 |
03/06/2003 |
EBI DYNAFIX COMPRESSION BONE SCREW |
EBI, L.P. |
| K020887 |
03/18/2002 |
EBI AIS SPINE SYSTEM |
EBI, L.P. |
| K040833 |
03/31/2004 |
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM |
EBI, L.P. |
| K021091 |
04/04/2002 |
EBI XFIX DFS SYSTEM |
EBI, L.P. |
| K040908 |
04/07/2004 |
EBI DISTAL RADIUS PLATING SYSTEM |
EBI, L.P. |
| K040935 |
04/09/2004 |
EBI XFIX DFS SYSTEM |
EBI, L.P. |
| K031354 |
04/29/2003 |
EBI OMEGA21 SPINAL FIXATION SYSTEM |
EBI, L.P. |
| K031355 |
04/29/2003 |
EBI SPINELINK - II SPINAL FIXATION SYSTEM |
EBI, L.P. |
| K011697 |
06/01/2001 |
EBI XFIX ACCESS PELVIC FIXATOR |
EBI, L.P. |
| K151459 |
06/01/2015 |
Integra Total Ankle Replacement System |
Ascension Orthopedics |
| K022319 |
07/17/2002 |
EBI XFIX DFS SYSTEM |
EBI, L.P. |
| K132250 |
07/19/2013 |
INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM |
INTEGRA LIFE SCIENCES CORPORATION |
| K042268 |
08/23/2004 |
EBI CAS SPINE SPACER SYSTEM |
EBI, L.P. |
| K142413 |
08/28/2014 |
TITAN Modular Total Shoulder System |
Ascension Orthopedics |
| K023133 |
09/20/2002 |
MODIFICATION TO EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM |
EBI, L.P. |
| K023204 |
09/25/2002 |
MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM |
EBI, L.P. |
| K023324 |
10/04/2002 |
MODIFICATION TO EBI XFIX DFS SYSTEM |
EBI, L.P. |
| K042772 |
10/05/2004 |
EBI ARRAY SPINAL FIXATION SYSTEM AND SPINELINK II SPINAL FIXATION DEVICE |
EBI, L.P. |
| K023399 |
10/09/2002 |
EBI XFIX DFS SYSTEM |
EBI, L.P. |
| K033312 |
10/14/2003 |
EBI TOP LOADING MAS SPINAL FIXATION SYSTEM |
EBI, L.P. |
| K013739 |
11/13/2001 |
MODIFICATION TO EBI XFIX DFS SYSTEM |
EBI, L.P. |
| K033635 |
11/19/2003 |
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM |
EBI, L.P. |
| K003764 |
12/06/2000 |
MODIFICATION TO EBI SPINELINK SYSTEM |
EBI, L.P. |
| K014137 |
12/17/2001 |
MODIFICATION TO EBI OMEGA 21 SYSTEM |
EBI, L.P. |
| K024248 |
12/23/2002 |
MODIFICATION TO EBI XFIX DFS SYSTEM METAPHYSEAL CORRECTION SYSTEM |
EBI, L.P. |
| K014276 |
12/27/2001 |
MODIFICATION TO EBI XFIX DFS SYSTEM |
EBI, L.P. |
|
|