FDA 510(k) Applications Submitted by SOFAMOR DANEK USA,INC.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K991364 |
04/20/1999 |
MODIFICATION TO TENOR SPINAL SYSTEM-PLATES |
SOFAMOR DANEK USA,INC. |
K982686 |
08/03/1998 |
MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEM |
SOFAMOR DANEK USA,INC. |
K992928 |
08/31/1999 |
CD HORIZON SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
K991036 |
03/29/1999 |
DANEK PLATE AND SCREW SYSTEM |
SOFAMOR DANEK USA,INC. |
K964623 |
11/18/1996 |
TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
K980184 |
01/20/1998 |
CD SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
K950717 |
02/16/1995 |
AUGMENT-T POSTERIOR SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
K970806 |
03/05/1997 |
ACPII ANTERIOR CERVICAL PLATE SYSTEM |
SOFAMOR DANEK USA,INC. |
K951164 |
03/14/1995 |
CD LIBERTY POSTERIOR SPINCAL SYSTEM |
SOFAMOR DANEK USA,INC. |
K991031 |
03/29/1999 |
COLORADO II SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
K991198 |
04/08/1999 |
DYNA-LOK PLUS SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
K981676 |
05/12/1998 |
CD HORIZON SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
K953076 |
06/30/1995 |
TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM |
SOFAMOR DANEK USA,INC. |
K962708 |
07/12/1996 |
TITANIUM CD HORIZON SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
K982490 |
07/17/1998 |
TENOR SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
K973145 |
08/22/1997 |
TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEM |
SOFAMOR DANEK USA,INC. |
K982990 |
08/26/1998 |
TSRH SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
K963642 |
09/12/1996 |
INCL II ENDOSCOPE |
SOFAMOR DANEK USA,INC. |
K963780 |
09/20/1996 |
DUAL ROD ANTERIOR FIXATOR SYSTEM |
SOFAMOR DANEK USA,INC. |
K973854 |
10/03/1997 |
ORION ANTERIOR CERVICAL PLATE SYSTEM |
SOFAMOR DANEK USA,INC. |
K954645 |
10/10/1995 |
TITANIUM GDLH POSTERIOR SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
K983672 |
10/19/1998 |
DYNA-LOK SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
K983706 |
10/21/1998 |
MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM |
SOFAMOR DANEK USA,INC. |
K974017 |
10/22/1997 |
TIMESH SYSTEM |
SOFAMOR DANEK USA,INC. |
K964254 |
10/24/1996 |
TITANIUM LIBERTY POSTERIOR SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
K964275 |
10/25/1996 |
ALPHA POSTERIOR SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
K955365 |
11/22/1995 |
COMPACT COTREL-DUBOUSSET (CCD) SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
K984360 |
12/07/1998 |
COLORADO II SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
K955807 |
12/22/1995 |
COTREL-DUBOUSSET (CD) SPINAL |
SOFAMOR DANEK USA,INC. |
K961633 |
04/29/1996 |
CD HORIZON SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
K963655 |
09/12/1996 |
CD HORIZON ANTERIOR SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
K964159 |
10/16/1996 |
CD SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
K965193 |
12/24/1996 |
LIBERTY ANTERIOR SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
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