FDA 510(k) Applications Submitted by SHARON A STAROWICZ
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K040655 |
03/12/2004 |
SWIFT ANTERIOR CERVICAL PLATE SYSTEM |
DEPUY SPINE,INC |
K051024 |
04/22/2005 |
EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
K041119 |
04/29/2004 |
EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
K041203 |
05/07/2004 |
SUMMIT OCT SPINAL SYSTEM |
DEPUY SPINE, INC. |
K051296 |
05/18/2005 |
SIJF CANNULATED SCREW SYSTEM |
DEPUY SPINE, INC. |
K081917 |
07/03/2008 |
DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS |
DEPUY SPINE, INC. |
K071927 |
07/12/2007 |
MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT |
DEPUY SPINE, A JOHNSON & JOHNSON COMPANY |
K042508 |
09/15/2004 |
SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM |
DEPUY SPINE, INC. |
K052546 |
09/16/2005 |
AEGIS ANTERIOR LUMBAR PLATE SYSTEM |
DEPUY SPINE, INC. |
K042544 |
09/20/2004 |
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM |
DEPUY SPINE, INC. |
K062814 |
09/20/2006 |
PIPELINE II ACCESS SYSTEM |
DEPUY SPINE, INC. |
K963969 |
10/03/1996 |
INDIGO PORTABLE LASER SYSTEM WITH TEMPERATURE FEEDBACK -MODEL IDL 830 (POWER OPTIONS : 25, 20, 15 & 10 WATTS) INDIGO FIB |
INDIGO MEDICAL, INC. |
K093390 |
10/29/2009 |
HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025 |
DEPUY SPINE, INC. |
K043308 |
12/01/2004 |
MODIFICATION TO: HEALOS BONE GRAFT MATERIAL |
DEPUY SPINE, INC. |
K043406 |
12/10/2004 |
VERTEBROPLASTIC RADIOPAQUE BONE CEMENT |
DEPUY SPINE,INC |
K961433 |
04/15/1996 |
EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BONE SCREWS |
ELECTRO-BIOLOGY, INC. |
K963261 |
08/20/1996 |
EBI THERMAL THERAPY SYSTEM |
ELECTRO-BIOLOGY, INC. |
K964533 |
11/12/1996 |
EBI SPINELINK SYSTEM |
ELECTRO-BIOLOGY, INC. |
K964797 |
11/29/1996 |
EBI SPINELINK SYSTEM |
ELECTRO-BIOLOGY, INC. |
K955730 |
12/18/1995 |
EBI ANTERIOR CERVICAL SPINE SYSTEM |
ELECTRO-BIOLOGY, INC. |
|
|