FDA 510(k) Applications Submitted by VIVIAN KELLY, MS, RAC

FDA 510(k) Number Submission Date Device Name Applicant
K050048 01/10/2005 HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS CORP
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.
K060514 02/27/2006 STRYKER PLATING SYSTEM HOWMEDICA OSTEONICS CORP
K050512 03/01/2005 STRYKER LOCKED PLATING SYSTEM HOWMEDICA OSTEONICS CORP.
K060613 03/07/2006 VARIAX LOCKING PLATE SYSTEM HOWMEDICA OSTEONICS CORP.
K060798 03/24/2006 STRYKER PLATING SYSTEM HOWMEDICA OSTEONICS CORP.
K981261 04/07/1998 HOWMEDICA SCN NAIL HOWMEDICA CORP.
K121130 04/13/2012 POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS BIOMET SPINE
K091067 04/14/2009 5.5 POLARIS SPINAL SYSTEM BIOMET SPINE
K071082 04/17/2007 STRYKER MODULAR HIP SYSTEM HOWMEDICA OSTEONICS CORP
K071092 04/18/2007 ASNIS MICRO CANNULATED SCREW HOWMEDICA OSTEONICS CORP.
K041001 04/19/2004 OMEGA 2 SYSTEM HOWMEDICA OSTEONICS CORP.
K091381 05/11/2009 IBEX SPINAL SYSTEM EBI, L.P.
K051306 05/19/2005 HOFFMANN II MRI EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS CORP.
K081395 05/19/2008 SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM BIOMET SPINE
K081501 05/29/2008 SOLITAIRE ANTERIOR SPINAL SYSTEM BIOMET SPINE
K061493 05/31/2006 APEX PINS STRYKER HOWMEDICA OSTEONICS
K131615 06/03/2013 POLARIS SPINAL SYSTEM BIOMET SPINE (AKA EBI, LLC)
K972108 06/05/1997 ALTA INTRAMEDULLARY ROD SYSTEM HOWMEDICA CORP.
K081636 06/11/2008 PEEK-OPTIMA ALIF SPACER BIOMET SPINE
K051590 06/15/2005 T2 ANKLE ARTHRODESIS NAIL HOWMEDICA OSTEONICS CORP.
K021996 06/18/2002 BOLTON PTA CATHETER Bolton Medical, Inc.
K051624 06/20/2005 T2 RECON NAIL SYSTEM HOWMEDICA OSTEONICS CORP
K041706 06/23/2004 HOFFMANN II FOOT RING HOWMEDICA OSTEONICS CORP.
K041709 06/23/2004 NUMELOCK II SYSTEM HOWMEDICA OSTEONICS CORP.
K031941 06/24/2003 HOFFMANN II COMPACT BALTIMORE COUPLING HOWMEDICA OSTEONICS CORP.
K031959 06/25/2003 STRYKER PLATING SYSTEM PERIARTICULAR PLATES HOWMEDICA OSTEONICS CORP.
K972479 07/01/1997 ALTA PLATING SYSTEM HOWMEDICA CORP.
K071881 07/09/2007 TRIATHLON PKR SYSTEM HOWMEDICA OSTEONICS CORP
K081952 07/09/2008 SYNERGY SPINAL SYSTEM (6.35 POLARIS) BIOMET SPINE
K982463 07/15/1998 EXTRACRANIAL RADIOTHERAPY SYSTEM HOWMEDICA, INC.
K982494 07/17/1998 BWM SPINE SYSTEM HOWMEDICA CORP.
K051948 07/18/2005 AVON PATELLO-FEMORAL JOINT PROSTHESIS HOWMEDICA OSTEONICS CORP
K032244 07/22/2003 GAMMA 3 NAIL SYSTEM HOWMEDICA OSTEONICS CORP.
K982602 07/27/1998 RETROGRADE ROD SYSTEM HOWMEDICA CORP.
K042019 07/27/2004 HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS CORP.
K972811 07/28/1997 HOWMEDICA FULLY THREADED SCREWS HOWMEDICA CORP.
K052037 07/28/2005 MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS CORP
K972813 07/29/1997 GAMMA LOCKING NAIL SYSTEM HOWMEDICA CORP.
K092336 08/04/2009 C-THRU SPINAL SYSTEM EBI, L.P.
K122378 08/06/2012 NEXTGEN ALTIUS OCT SYSTEM BIOMET SPINE (AKA EBI, LLC)
K982873 08/14/1998 ZETA MULTIZONE SCN LOCKING NAIL HOWMEDICA CORP.
K032523 08/15/2003 T2 NAILING SYSTEM HOWMEDICA OSTEONICS CORP.
K032579 08/21/2003 S2 NAIL SYSTEM HOWMEDICA OSTEONICS CORP.
K082406 08/21/2008 EXPANDABLE PEEK-OPTIMA IMPLANT EBI, L.P.
K092574 08/21/2009 ESL SPINAL SYSTEM EBI, L.P.
K982958 08/24/1998 ZETA MULTIZONE LOCKING NAIL SYSTEM HOWMEDICA CORP.
K062498 08/25/2006 PROFYLE SYSTEM HOWMEDICA OSTEONICS CORP.
K042396 09/02/2004 T2 PROXIMAL HUMERAL NAIL HOWMEDICA OSTEONICS CORP.
K032898 09/17/2003 T2 RECON NAIL SYSTEM HOWMEDICA OSTEONICS CORP.
K983358 09/24/1998 G/K SFN AND STN LOCKING NAILS HOWMEDICA, INC.
K033145 09/30/2003 HOFFMANN II PELVIC CLAMP HOWMEDICA OSTEONICS CORP.
K983528 10/08/1998 MICRO DYNAMIC MESH HOWMEDICA CORP.
K052917 10/17/2005 STRYKER COMPARTMENTAL KNEE SYSTEM HOWMEDICA OSTEONICS CORP
K973982 10/20/1997 ORBITAL RECONSTRUCTION PLATES HOWMEDICA, INC.
K063225 10/24/2006 METAIZEAU NAILING SYSTEM HOWMEDICA OSTEONICS CORP.
K053038 10/27/2005 HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS CORP
K033476 11/03/2003 MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS CORP.
K974289 11/14/1997 EPI-UNION PLATING SYSTEM HOWMEDICA, INC.
K103393 11/19/2010 POLARIS SPINAL SYSTEM BIOMET SPINE
K093629 11/23/2009 SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM BIOMET SPINE
K984251 11/27/1998 XIA SPINE SYSTEM HOWMEDICA, INC.
K053348 12/02/2005 STRYKER ORTHOPAEDICS RFID INSTRUMENTATION HOWMEDICA OSTEONICS CORP
K113593 12/05/2011 NEXTGEN ALTIUS OCT SYSTEM BIOMET SPINE (AKA EBI, LLC)
K043404 12/10/2004 MODIFICATION TO T2 PROXIMAL HUMERAL NAIL HOWMEDICA OSTEONICS CORP.
K053472 12/14/2005 HOFFMANN II MRI EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS CORP
K974720 12/18/1997 HOWMEDICA(R) FULLY THREADED SCREWS HOWMEDICA, INC.
K033968 12/22/2003 HANSSON PIN SYSTEM HOWMEDICA OSTEONICS CORP.
K034002 12/24/2003 GAMMA3 NAIL SYSTEM HOWMEDICA OSTEONICS CORP.
K063875 12/29/2006 STRYKER FOOT PLATING SYSTEM HOWMEDICA OSTEONICS CORP.
K100409 02/16/2010 POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM BIOMET SPINE (AKA EBI, LLC)
K082187 08/04/2008 BIOMET ANTERIOR LUMBAR PLATE EBI, L.P.
K123451 11/09/2012 POLARIS SPINAL SYSTEM - BALLISTA II RODS BIOMET SPINE (AKA EBI, LLC)
K132373 07/30/2013 BIOMET ACCESS SYSTEM BIOMET SPINE (AKA EBI, LLC)
K123549 11/19/2012 POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM BIOMET SPINE (AKA EBI, LLC)
K133746 12/09/2013 POLARIS SPINAL SYSTEM BIOMET SPINE (AKA EBI, LLC)
K111957 07/11/2011 POLARIS SPINAL SYSTEM BIOMET SPINE (EBI LLC)


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