FDA 510(k) Applications Submitted by PATRICIA S ANDBORN BERES

FDA 510(k) Number Submission Date Device Name Applicant
K030048 01/06/2003 HA PMI FEMORAL HIP STEM BIOMET ORTHOPEDICS, INC.
K120121 01/17/2012 COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE BIOMET, INC.
K050124 01/19/2005 POROUS COATED ACETABULAR COMPONENTS BIOMET, INC.
K123297 10/22/2012 COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM BIOMET MANUFACTUTING CORP.
K984054 11/13/1998 AGC V2 REVISION KNEE SYSTEM BIOMET, INC.
K030055 01/06/2003 MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS BIOMET, INC.
K050028 01/06/2005 MAESTRO CARPAL HEMIARTHROPLASTY BIOMET MANUFACTURING, INC.
K000254 01/28/2000 PAR 5 ACETABULAR COMPONENT BIOMET, INC.
K020381 02/05/2002 EXPANDABLE KNEE BIOMET ORTHOPEDICS, INC.
K130390 02/15/2013 COMPREHENSIVE CONVERTIBLE GLENOID BIOMET MANUFACTURING, INC.
K030501 02/19/2003 X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS BIOMET, INC.
K080426 02/20/2008 MAESTRO WRIST FRACTURE IMPLANT BIOMET MANUFACTURING CORP.
K030710 03/06/2003 BIO-MODULAR SHOULDER SYSTEM BIOMET, INC.
K040611 03/08/2004 MODULAR RADIAL HEAD REPLACEMENT DEVICE BIOMET, INC.
K000764 03/09/2000 PEDIATRIC FIXATION RODS BIOMET, INC.
K960984 03/11/1996 SHP HIP SYSTEM-FEMORAL COMPONENTS/ACETABULAR COMPONENTS/MODULAR HEADS/CENTRALIZERS BIOMET, INC.
K990830 03/12/1999 MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS BIOMET, INC.
K060694 03/15/2006 MODULAR HYBRID GLENOID BIOMET MANUFACTURING CORP.
K030861 03/18/2003 HA PMI FLANGED ACETABULAR COMPONENT BIOMET, INC.
K020905 03/20/2002 NBX - NON-BRIDGING EXTERNAL FIXATOR BIOMET ORTHOPEDICS, INC.
K040770 03/25/2004 VANGUARD PATELLA COMPONENTS BIOMET MANUFACTURING, INC.
K121183 04/18/2012 COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS BIOMET CORPORATION
K031280 04/22/2003 ULTRA-DRIVE 3 BIOMET, INC.
K041089 04/26/2004 OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM BIOMET MANUFACTURING, INC.
K001350 04/28/2000 PATIENT MATCHED TITANIUM ALLOY TROCHLEA BIOMET, INC.
K001374 05/01/2000 PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT BIOMET MANUFACTURING, INC.
K021380 05/01/2002 OSS LES PROXIMAL FEMORAL COMPONENT BIOMET, INC.
K061312 05/10/2006 36MM BIOLOX DELTA CERAMIC HEADS BIOMET, INC.
K971816 05/16/1997 ATLAS FRACTURE PROXIMAL HUMERAL NAIL BIOMET, INC.
K011554 05/18/2001 LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT BIOMET, INC.
K991807 05/26/1999 TITANIUM LOW PROFILE SCREWS BIOMET, INC.
K971938 05/27/1997 REPICCI II UNICONDYLAR KNEE BIOMET, INC.
K051385 05/27/2005 EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE BIOMET, INC.
K101475 05/28/2010 COMPRESS ANTI-ROTATION SPINDLES BIOMET MANUFACTURING CORP.
K021799 05/31/2002 CEMENTED FEMORAL HEAD RESURFING DEVICE BIOMET ORTHOPEDICS, INC.
K981967 06/04/1998 WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE ARTHROTEK/BIOMET, INC.
K051569 06/14/2005 RINGLOC BI-POLAR ACETABULAR COMPONENT BIOMET, INC.
K051570 06/14/2005 AVL HINGE KNEE SYSTEM BIOMET, INC.
K111746 06/21/2011 COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS) BIOMET, INC.
K992119 06/23/1999 BIO-MODULAR SHOULDER SYSTEM BIOMET, INC.
K061776 06/23/2006 ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE ARTHROTEK, INC.
K191814 07/05/2019 Alliance Glenoid Zimmer Inc.
K002057 07/06/2000 BROOKER TIBIA NAILS BIOMET ORTHOPEDICS, INC.
K041872 07/09/2004 ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL FEMORAL PEGS BIOMET MANUFACTURING CORP.
K051975 07/21/2005 POROUS COATED DISCOVERY ELBOW BIOMET, INC.
K002278 07/26/2000 BROOKER FEMORAL NAILS BIOMET ORTHOPEDICS, INC.
K042029 07/28/2004 X-SERIES INTEGRAL RPP FEMORAL COMPONENTS BIOMET, INC.
K042032 07/28/2004 MAESTRO TOTAL WRIST BIOMET, INC.
K022515 07/30/2002 BIOMET CALCANEAL PLATE BIOMET ORTHOPEDICS, INC.
K042091 08/03/2004 BIOLOX DELTA CERAMIC HEADS BIOMET, INC.
K012551 08/07/2001 LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE BIOMET, INC.
K992899 08/30/1999 BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS BIOMET, INC.
K983035 08/31/1998 CUSTOM FLANGED ACETABULAR COMPONENT BIOMET, INC.
K122770 09/10/2012 BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831 BIOMET MANUFACTURING CORP.
K023188 09/24/2002 PRESS-FIT HEAD RESURFACING DEVICE BIOMET ORTHOPEDICS, INC.
K042774 10/05/2004 MALLORY-HEAD MODULAR CALCAR STEMS WITH INTERLOCKING SLOTS BIOMET, INC.
K033233 10/06/2003 LACTOSORB TIBIAL L-15 SCREW AND WASHER BIOMET, INC.
K082996 10/08/2008 BIOLOX DELTA OPTION CERAMIC HEADS BIOMET, INC.
K023409 10/10/2002 HA X-SERIES BI-METRIC HIP FEMORAL COMPONENTS BIOMET, INC.
K033280 10/10/2003 DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM BIOMET, INC.
K063139 10/16/2006 SPINAL STABILIZING SPHERE SYSTEM BIOMET SPINE
K042989 10/29/2004 RX90 LOW PROFILE ACETABULAR SYSTEM BIOMET, INC.
K033489 11/04/2003 AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN BIOMET, INC.
K993972 11/23/1999 DISPOSABLE INFUSION PUMP KIT BIOMET, INC.
K153398 11/24/2015 Comprehensive SRS/Nexel Elbow BIOMET MANUFACTURING CORP.
K033718 11/26/2003 MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE ARTHROTEK, INC.
K974558 12/05/1997 SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEM BIOMET, INC.
K024037 12/06/2002 NARROW ASCENT INTERLOK FEMORAL COMPONENTS BIOMET, INC.
K984408 12/09/1998 130 MODIFIED INTEGRAL FEMORAL COMPONENT BIOMET, INC.
K213856 12/10/2021 Identity Shoulder System Zimmer Inc.
K093803 12/11/2009 BIO-MODULAR REVERSE SHOLDER BIOMET MANUFACTURING CORP.
K033871 12/12/2003 IM TOTAL FEMUR BIOMET, INC.
K043537 12/22/2004 TAPERLOC 12/14 TAPER FEMORAL COMPONENTS BIOMET, INC.
K052089 08/02/2005 XR-SERIES BI-METRIC FEMORAL COMPONENTS BIOMET MANUFACTURING, INC.
K042841 10/14/2004 M2A/C2A ACETABULAR SYSTEM BIOMET, INC.
K110201 01/24/2011 EXPLOR RADIAL HEAD PLATING SYSTEM BIOMET, INC.
K960363 01/25/1996 BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143 BIOMET, INC.
K980370 01/30/1998 BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATOR BIOMET, INC.
K110271 01/31/2011 MAESTRO WRIST PLATING SYSTEM BIOMET MANUFACTURING CORP.
K110320 02/03/2011 COMPREHENSIVEPROXIMAL HUMERAL PLATING SYSTEM BIOMET MANUFACTURING CORP.
K080330 02/06/2008 SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER BIOMET, INC.
K970501 02/10/1997 PEGGED ACETABULAR COMPONENT BIOMET, INC.
K960643 02/14/1996 ADVANTAGE MAPF HIP FEMORAL COMPONENT BIOMET, INC.
K980665 02/20/1998 REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS BIOMET, INC.
K020580 02/21/2002 X-SERIES BI-METRIC HIP FEMORAL COMPONENTS BIOMET, INC.
K090473 02/24/2009 DISCOVERY ELBOW - X-SMALL BIOMET MANUFACTURING CORP.
K080642 03/06/2008 COMPREHENSIVE REVERSE SHOULDER BIOMET, INC.
K020761 03/07/2002 POWER TEK II BIOMET, INC.
K961260 04/02/1996 KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY BIOMET, INC.
K011138 04/13/2001 OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT BIOMET, INC.
K081244 05/01/2008 LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS BIOMET TRAUMA
K131353 05/10/2013 COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE BIOMET MANUFACTURING CORP.
K031693 06/02/2003 MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA BIOMET, INC.
K943025 06/27/1994 FREEMAN/SAMUELSON TOTAL KNEE SYSTEM BIOMET, INC.
K132239 07/18/2013 COMPREHENSIVE REVERSE SHOULDER SCREWS BIOMET MANUFACTURING CORP.
K032507 08/14/2003 INTERLOK BIO-MODULAR HUMERAL STEMS BIOMET, INC.
K032895 09/17/2003 BI-ANGULAR SHOULDER SYSTEM BIOMET, INC.
K072804 10/01/2007 COMPREHENSIVE RS SHOULDER SYSTEM BIOMET MANUFACTURING CORP.
K062994 10/02/2006 LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS BIOMET MANUFACTURING CORP.
K062995 10/02/2006 M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT BIOMET MANUFACTURING CORP.
K945028 10/13/1994 FINN KNEE SYSTEM BIOMET, INC.
K113069 10/17/2011 COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY BIOMET MANUFACTURING CORP.
K113121 10/21/2011 COMPREHENSIVE REVERSE SHOULDER BIOMET MANUFACTURING, INC.
K964431 11/05/1996 ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS) BIOMET, INC.
K013790 11/14/2001 CALCIGEN-S BONE VOID FILER BIOMET ORTHOPEDICS, INC.
K053299 11/25/2005 REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT BIOMET MANUFACTURING, INC.
K083779 12/19/2008 MAK OSS KNEE FEMORAL COMPONENTS BIOMET MANUFACTURING CORP.
K150424 02/19/2015 JuggerStitch Meniscal Repair Device BIOMET MANUFACTURING CORP.
K152754 09/24/2015 COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS) BIOMET MANUFACTURING CORP.
K181307 05/17/2018 Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow Zimmer Inc
K211729 06/04/2021 Comprehensive« Convertible Glenoid - Vivacit-E Liner Biomet Manufacturing Corp.
K151615 06/15/2015 TiTHON Staple with OsseoTi Technology BIOMET MANUFACTURING CORP.
K202232 08/07/2020 Comprehensive Vault Reconstruction System Biomet Manufacturing Corp.
K172502 08/18/2017 Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate Biomet Manufacturing Corp
K193038 10/31/2019 Comprehensive Shoulder System Biomet Manufacturing Corp.
K173411 11/01/2017 Comprehensive Segmental Revision System (SRS) Biomet Manufacturing Corp.
K193180 11/18/2019 Alliance Augmented Glenoid Zimmer Inc.


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