FDA 510(k) Applications Submitted by MARGARET CROWE

FDA 510(k) Number Submission Date Device Name Applicant
K971206 03/12/1997 MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATING HOWMEDICA CORP.
K091976 07/01/2009 BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL BIOMET TRAUMA
K092528 08/18/2009 BIOMET FORERUNNER LOCKING PLATE SYSTEM BIOMET TRAUMA (AKA EBI, LP)
K993670 11/01/1999 MODIFIED LONG LENGTH GAMMA NAIL HOWMEDICA OSTEONICS CORP.
K093761 12/07/2009 OPTILOCK VL (VARIABLE ANGLE LOCKING) DISTAL RADIUS PLATING SYSTEM BIOMET TRAUMA (AKA EBI, LP)
K113796 12/23/2011 SOLITAIRE-C CERVICAL SPACER SYSTEM EBI, LLC
K093983 12/24/2009 SMPLE PLATE AND SCREWS BIOMET TRAUMA (AKA EBI, LP)
K190402 02/19/2019 Triathlon Total Knee System-Additional Components Stryker Orthopaedics (aka Howmedica Osteonics Corp.)
K173849 12/19/2017 Triathlon Total Knee System Stryker Orthopaedics
K010170 01/18/2001 TRIDENT POROUS TITANIUM ACETABULAR COMPONENT HOWMEDICA OSTEONICS CORP.
K040128 01/21/2004 MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS HOWMEDICA OSTEONICS CORP
K960297 01/22/1996 MANDIBULAR BONE DISTRACTOR II HOWMEDICA CORP.
K040267 02/05/2004 TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEE HOWMEDICA OSTEONICS CORP
K980626 02/18/1998 DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION HOWMEDICA CORP.
K980632 02/19/1998 DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION HOWMEDICA CORP.
K980713 02/24/1998 FEMORAL AND TIBIAL PLUGS OF INTERAX TOTAL KNEE SYSTEM HOWMEDICA CORP.
K120557 02/24/2012 SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35 BIOMET SPINE & BONE HEALING TECHNOLOGIES
K970758 03/03/1997 DURACON EXTRA-SMALL STABILIZER TIBIAL INSERT & BASEPLATE HOWMEDICA CORP.
K110650 03/04/2011 ZYSTON ARC INTERBODY SPACER BIOMET SPINE (AKA EBI, LLC)
K960976 03/11/1996 KINEMATIC II REPLACEMENT TIBIAL INSERTS HOWMEDICA CORP.
K980925 03/11/1998 DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION HOWMEDICA CORP.
K980926 03/11/1998 DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION HOWMEDICA CORP.
K020830 03/14/2002 SCORPIO INSET PATELLAR COMPONENT HOWMEDICA OSTEONICS CORP.
K020841 03/15/2002 AVON PATELLAR COMPONENT HOWMEDICA OSTEONICS CORP.
K040749 03/23/2004 MODULAR REPLACEMENT SYSTEM CEMENTED STEMS HOWMEDICA OSTEONICS CORP
K031217 04/17/2003 GMRS PRESS FIT STEMS WITH PUREFIX HA HOWMEDICA OSTEONICS
K961482 04/18/1996 DURACON INSET PATELLA WITH CENTRAL PEG HOWMEDICA CORP.
K961483 04/18/1996 DURACON ALL POLYETHYLENE PATELLA II HOWMEDICA CORP.
K971550 04/28/1997 KINEMATIC ALL-POLYETHYLENE PATELLA WITH THREE PEGS HOWMEDICA CORP.
K041160 05/03/2004 AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT HOWMEDICA OSTEONICS CORP.
K021451 05/06/2002 DURACON CS TIBIAL INSERT HOWMEDICA OSTEONICS CORP.
K031480 05/12/2003 GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT HOWMEDICA OSTEONICS CORP.
K111376 05/16/2011 CONSTRUX EXTERNAL FIXATION DEVICE EBI, LLC
K031729 06/04/2003 TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM HOWMEDICA OSTEONICS CORP.
K972401 06/26/1997 HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIMAL TIBIAL SEGMENTS HOWMEDICA CORP.
K972551 07/08/1997 ARTISAN PULSE LAVAGE SYSTEM HOWMEDICA CORP.
K972752 07/23/1997 DURACON CONVERSION METAL BACKED PATELLA HOWMEDICA CORP.
K022403 07/23/2002 GMRS PRESS FIT STEMS WITH PUREFIX HA HOWMEDICA OSTEONICS CORP.
K032264 07/23/2003 MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM HOWMEDICA OSTEONICS CORP.
K032479 08/12/2003 HOWMEDICA OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS HOWMEDICA OSTEONICS CORP.
K963242 08/19/1996 DURACON POSTERIOR FEMORAL SPACER HOWMEDICA CORP.
K973121 08/20/1997 INTERAX TOTAL KNEE SYSTEM HOWMEDICA CORP.
K012776 08/20/2001 DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT HOWMEDICA OSTEONICS CORP.
K032581 08/21/2003 GLOBAL MODULAR REPLACEMENT SYSTEM ANTEVERTED PROMIMAL FEMORAL COMPONENT HOWMEDICA OSTEONICS CORP.
K022799 08/23/2002 TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE HOWMEDICA OSTEONICS CORP.
K973164 08/25/1997 HOWMEDICA TOTAL STABILIZER KNEE COMPONENTS HOWMEDICA CORP.
K032829 09/11/2003 SCORPIO LOW PROFILE TIBIAL TRAY HOWMEDICA OSTEONICS CORP.
K023087 09/17/2002 GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS) HOWMEDICA OSTEONICS CORP.
K963796 09/23/1996 KINEMAX PLUS MODULAR STABILIZER FEMORAL COMPONENT AND FEMORAL SPACERS HOWMEDICA CORP.
K122989 09/26/2012 BIOMET LATERAL SPACER SYSTEM BIOMET SPINE (AKA EBI, LLC)
K102843 09/29/2010 MAC MALE ADAPTER BIOMET TRAUMA (AKA EBI LLC)
K093057 09/30/2009 BIOMET VISION FOOTRING SYSTEM EBI, L.P.
K954559 10/02/1995 HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM HOWMEDICA CORP.
K013475 10/19/2001 TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING HOWMEDICA OSTEONICS CORP.
K023692 11/04/2002 GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER HOWMEDICA OSTEONICS CORP.
K023724 11/05/2002 DURACON CS LIPPED EXTRA SMALL TIBIAL INSERT HOWMEDICA OSTEONICS CORP.
K955305 11/20/1995 PCA +15MM MODULAR FEMORAL HEAD HOWMEDICA CORP.
K955306 11/20/1995 OMEGA+ COMPRESSION SCREW SYSTEM HOWMEDICA CORP.
K964951 12/10/1996 KINEMAX PLUS TIBIAL SPACERS HOWMEDICA CORP.
K093880 12/18/2009 PEANUT GROWTH CONTROL PLATING SYSTEM EBI, L.P.
K965164 12/24/1996 HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR HOWMEDICA CORP.


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