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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