FDA 510(k) Applications Submitted by EBI, L.P.

FDA 510(k) Number Submission Date Device Name Applicant
K031645 05/28/2003 EBI XFIX DFS SYSTEM EBI, L.P.
K031424 05/06/2003 EBI SPINELINK SPINAL FIXATION SYSTEM EBI, L.P.
K032390 08/04/2003 MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM EBI, L.P.
K060148 01/19/2006 EBI VERTEBROPLASTY SYSTEMS EBI, L.P.
K061978 07/13/2006 EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM EBI, L.P.
K062494 08/25/2006 EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM EBI, L.P.
K062685 09/08/2006 EBI ARAY SPINAL SYSTEM EBI, L.P.
K062810 09/19/2006 SOLITAIRE ANTERIOR SPINAL SYSTEM EBI, L.P.
K063346 11/03/2006 PRO OSTEON 500R EBI, L.P.
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.
K022319 07/17/2002 EBI XFIX DFS SYSTEM EBI, L.P.
K042268 08/23/2004 EBI CAS SPINE SPACER SYSTEM EBI, L.P.
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.
K061016 04/13/2006 EBI ESL PEEK-OPTIMA SPINE SYSTEM EBI, L.P.
K060379 02/14/2006 EBI ANTERIOR CERVICAL PLATE SYSTEM EBI, L.P.
K061098 04/19/2006 EBI OPTILOCK PERIARTICULAR PLATING SYSTEM EBI, L.P.
K061441 05/24/2006 EBI 5.5 HELICAL FLANGE SPINAL SYSTEM EBI, L.P.
K061563 06/05/2006 EBI ARRAY SPINAL SYSTEM EBI, L.P.
K031423 05/06/2003 EBI P148 SPINAL FIXATION SYSTEM EBI, L.P.
K021749 05/28/2002 EBI DYNAFIX VS OSTEOTOMY SYSTEM EBI, L.P.
K010003 01/02/2001 EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM EBI, L.P.
K010179 01/19/2001 EBI VUECATH SPINAL ENDOSCOPIC SYSTEM EBI, L.P.
K970290 01/24/1997 EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM EBI, L.P.
K000513 02/16/2000 MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM EBI, L.P.
K031093 04/07/2003 EBI XFIX OPTIROM KNEE FIXATOR EBI, L.P.
K021312 04/25/2002 EBI DFS OPTIROM ELBOW FIXATOR EBI, L.P.
K011386 05/07/2001 EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE EBI, L.P.
K031732 06/04/2003 EBI ACUMEN SURGICAL NAVIGATION SYSTEM EBI, L.P.
K001794 06/14/2000 EBI ANTERIOR CERVICAL PLATE SYSTEM EBI, L.P.
K012024 06/28/2001 EBI XFIX DFS SYSTEM EBI, L.P.
K022419 07/24/2002 EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM EBI, L.P.
K023233 09/27/2002 EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM EBI, L.P.
K993649 10/29/1999 EBI XFIX DFS WRISTFIX SYSTEM EBI, L.P.
K993886 11/16/1999 EBI XFIX VISION FIXATION SYSTEM EBI, L.P.
K024129 12/16/2002 MODIFICATION TO EBI XFIX DFS SYSTEM EBI, L.P.
K003898 12/18/2000 EBI VUECATH SPINAL ENDOSCOPIC SYSTEM EBI, L.P.
K033918 12/18/2003 EBI LACTOSORB GRAFT CONTAINMENT SYSTEM EBI, L.P.
K000083 01/12/2000 EBI XFIX DFS RAIL SYSTEM EBI, L.P.
K000319 02/02/2000 EBI XFIX DFS SYSTEM EBI, L.P.
K001037 03/31/2000 MODIFICATION TO EBI SPINELINK SYSTEM EBI, L.P.
K001357 04/28/2000 MODIFICATION TO OMEGA 21 SYSTEM EBI, L.P.
K992515 07/28/1999 EBI XFIX DFS OPTIROM ELBOW FIXATOR EBI, L.P.
K992920 08/30/1999 EBI SPINELINK SYSTEM EBI, L.P.
K093057 09/30/2009 BIOMET VISION FOOTRING SYSTEM EBI, L.P.
K093880 12/18/2009 PEANUT GROWTH CONTROL PLATING SYSTEM EBI, L.P.
K013540 10/24/2001 EBI XFIX ACCESS PELVIC FIXATOR EBI, L.P.
K021031 03/29/2002 EBI XFIX RAIL SYSTEM EBI, L.P.
K013378 10/12/2001 EBI XFIX DFS SYSTEM EBI, L.P.
K020403 02/07/2002 MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATOR EBI, L.P.
K010437 02/13/2001 MODIFICATION TO EBI XFIX DFS RAIL SYSTEM EBI, L.P.
K010551 02/26/2001 EBI DYNAFIX VS OSTEOTOMY SYSTEM EBI, L.P.
K020681 03/04/2002 EBI OMEGA21 SPINAL FIXATION SYSTEM EBI, L.P.
K001358 04/28/2000 EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM EBI, L.P.
K011711 06/04/2001 MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM EBI, L.P.
K002980 09/25/2000 MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM EBI, L.P.
K993822 11/12/1999 EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM EBI, L.P.
K020141 01/16/2002 MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM EBI, L.P.
K021695 05/22/2002 EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM EBI, L.P.
K012516 08/06/2001 EBI SPINELINK - II SPINAL FIXATION SYSTEM EBI, L.P.
K014194 12/21/2001 MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM EBI, L.P.
K031919 06/23/2003 EBI XFIX DFS SYSTEM EBI, L.P.
K052239 08/17/2005 EBI DYNAFIX VISION FOOTPLATE SYSTEM EBI, L.P.
K042237 08/18/2004 EBI PERIARTICULAR PLATING SYSTEM EBI, L.P.
K100220 01/26/2010 POLARIS SPINAL SYSTEM EBI, L.P.
K090203 01/27/2009 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS EBI, L.P.
K100438 02/17/2010 POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM EBI, L.P.
K090523 02/26/2009 POLARIS SPINAL SYSTEM EBI, L.P.
K091381 05/11/2009 IBEX SPINAL SYSTEM EBI, L.P.
K092336 08/04/2009 C-THRU SPINAL SYSTEM EBI, L.P.
K082406 08/21/2008 EXPANDABLE PEEK-OPTIMA IMPLANT EBI, L.P.
K092574 08/21/2009 ESL SPINAL SYSTEM EBI, L.P.
K082187 08/04/2008 BIOMET ANTERIOR LUMBAR PLATE EBI, L.P.
K051724 06/27/2005 ACUMEN IMAGE GUIDED SURGICAL SYSTEM EBI, L.P.


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