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. |
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