FDA 510(k) Applications Submitted by Biomet Manufacturing Corp.

FDA 510(k) Number Submission Date Device Name Applicant
K150768 03/24/2015 JuggerKnot Soft Anchors BIOMET MANUFACTURING CORP.
K152868 09/30/2015 ExpressBraid Graft Manipulation BIOMET MANUFACTURING CORP.
K143037 10/22/2014 SnapShot Fixation System BIOMET MANUFACTURING CORP.
K153558 12/14/2015 Ventix Suture Anchor BIOMET MANUFACTURING CORP.
K214001 12/21/2021 Comprehensive« Shoulder System, Comprehensive« Reverse Shoulder System Biomet Manufacturing Corp.
K052888 10/13/2005 POROUS TITANIUM ACETABULAR AUGMENTS BIOMET MANUFACTURING CORP.
K052996 10/25/2005 POROUS TITANIUM ACETABULAR SHELLS BIOMET MANUFACTURING CORP.
K120030 01/04/2012 TAPERLOC COMPLETE SIZE 4MM AND XR 123 BIOMET MANUFACTURING CORP.
K100048 01/08/2010 E1 ANTIOXIDANT INFUSED TECHNOLOGY BIOMET MANUFACTURING CORP.
K110400 02/11/2011 TAPERLOC COMPLETE MICROPLASTY STEM BIOMET MANUFACTURING CORP.
K100469 02/18/2010 ARCOS INTERLOCKING DISTAL STEMS BIOMET MANUFACTURING CORP.
K081172 04/24/2008 COMPOSITE HITCH SUTURE ANCHOR BIOMET MANUFACTURING CORP.
K101336 05/12/2010 E1 AVANTAGE HEAD BIOMET MANUFACTURING CORP.
K061423 05/23/2006 M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS BIOMET MANUFACTURING CORP.
K121874 06/27/2012 G7 ACETABULAR SYSTEM BIOMET MANUFACTURING CORP.
K072161 08/06/2007 BIOMET FEMORAL LOCKING NAIL SYSTEM BIOMET MANUFACTURING CORP.
K072336 08/20/2007 REGENEREX POROUS TITANIUM SLEEVE AUGMENTS BIOMET MANUFACTURING CORP.
K062997 10/02/2006 ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS BIOMET MANUFACTURING CORP.
K073102 11/02/2007 BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS BIOMET MANUFACTURING CORP.
K093549 11/17/2009 44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM BIOMET MANUFACTURING CORP.
K063570 11/29/2006 BIOMET TIBIAL LOCKING NAIL SYSTEM BIOMET MANUFACTURING CORP.
K063614 12/05/2006 ALTRA FX HIP SYSTEM BIOMET MANUFACTURING CORP.
K063732 12/18/2006 MICROPLASTY TIBIAL TRAYS BIOMET MANUFACTURING CORP.
K103755 12/23/2010 TAPERLOC COMPLETE, SIZE 5 AND 6 BIOMET MANUFACTURING CORP.
K110555 02/28/2011 ARCOMXL ACTIVE ARTICULATION BIOMET MANUFACTURING CORP.
K140390 02/14/2014 TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS BIOMET MANUFACTURING CORP.
K140652 03/14/2014 POROUS COATED COMPREHENSIVE FRACTURE STEMS BIOMET MANUFACTURING CORP.
K131135 04/22/2013 BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS BIOMET MANUFACTURING CORP.
K130033 01/04/2013 TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO BIOMET MANUFACTURING CORP.
K122277 07/30/2012 OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM BIOMET MANUFACTURING CORP.
K123907 12/19/2012 PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS, BIOMET MANUFACTURING CORP.
K073637 12/26/2007 PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS BIOMET MANUFACTURING CORP.
K062558 08/30/2006 MESOSFOL SURGICAL FILM BIOMET MANUFACTURING CORP.
K080979 04/07/2008 STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT BIOMET MANUFACTURING CORP.
K063002 10/02/2006 ALTRA PRESS-FIT HIP SYSTEM BIOMET MANUFACTURING CORP.
K113550 12/01/2011 VANGUARD COMPLETE KNEE SYSTEM BIOMET MANUFACTURING CORP.
K083827 12/23/2008 ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES BIOMET MANUFACTURING CORP.
K121149 04/16/2012 VANGUARD SSK 360 REVISION KNEE SYSTEM BIOMET MANUFACTURING CORP.
K070015 01/03/2007 COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT BIOMET MANUFACTURING CORP.
K141219 05/12/2014 JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS BIOMET MANUFACTURING CORP.
K141263 05/15/2014 TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS BIOMET MANUFACTURING CORP.
K152262 08/11/2015 Ventix Knotless Anchors BIOMET MANUFACTURING CORP.
K132898 09/16/2013 A.L.P.S. CALCANEAL PLATING SYSTEM BIOMET MANUFACTURING CORP.
K062998 10/02/2006 COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG) BIOMET MANUFACTURING CORP.
K042321 08/26/2004 MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD BIOMET MANUFACTURING CORP.
K230540 02/27/2023 Patient Specific Planning SolutionÖ 3D Bone Models Biomet Manufacturing Corp.
K060121 01/17/2006 BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS BIOMET MANUFACTURING CORP.
K061681 06/15/2006 REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT BIOMET MANUFACTURING CORP.
K071934 07/13/2007 MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT BIOMET MANUFACTURING CORP.
K080426 02/20/2008 MAESTRO WRIST FRACTURE IMPLANT BIOMET MANUFACTURING CORP.
K060694 03/15/2006 MODULAR HYBRID GLENOID BIOMET MANUFACTURING CORP.
K101475 05/28/2010 COMPRESS ANTI-ROTATION SPINDLES BIOMET MANUFACTURING CORP.
K041872 07/09/2004 ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL FEMORAL PEGS BIOMET MANUFACTURING CORP.
K122770 09/10/2012 BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831 BIOMET MANUFACTURING CORP.
K153398 11/24/2015 Comprehensive SRS/Nexel Elbow BIOMET MANUFACTURING CORP.
K093803 12/11/2009 BIO-MODULAR REVERSE SHOLDER BIOMET MANUFACTURING CORP.
K110271 01/31/2011 MAESTRO WRIST PLATING SYSTEM BIOMET MANUFACTURING CORP.
K110320 02/03/2011 COMPREHENSIVEPROXIMAL HUMERAL PLATING SYSTEM BIOMET MANUFACTURING CORP.
K090473 02/24/2009 DISCOVERY ELBOW - X-SMALL BIOMET MANUFACTURING CORP.
K131353 05/10/2013 COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE BIOMET MANUFACTURING CORP.
K132239 07/18/2013 COMPREHENSIVE REVERSE SHOULDER SCREWS BIOMET MANUFACTURING CORP.
K072804 10/01/2007 COMPREHENSIVE RS SHOULDER SYSTEM BIOMET MANUFACTURING CORP.
K062995 10/02/2006 M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT BIOMET MANUFACTURING CORP.
K062994 10/02/2006 LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS BIOMET MANUFACTURING CORP.
K113069 10/17/2011 COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY BIOMET MANUFACTURING CORP.
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.
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.
K193038 10/31/2019 Comprehensive Shoulder System Biomet Manufacturing Corp.
K173411 11/01/2017 Comprehensive Segmental Revision System (SRS) Biomet Manufacturing Corp.
K071395 05/21/2007 BIOMET VISION FOOTRING SYSTEM BIOMET MANUFACTURING CORP.
K070274 01/29/2007 ECHO BI-METRIC PRESS-FIT STEMS BIOMET MANUFACTURING CORP.
K060303 02/06/2006 VANGUARD PS OPEN BOX POROUS FEMORAL COMPONENTS BIOMET MANUFACTURING CORP.
K060692 03/15/2006 COMPREHENSIVE PRIMARY SHOULDER STEMS BIOMET MANUFACTURING CORP.
K060716 03/17/2006 VERSA-DIAL HUMERAL HEAD PROSTHESIS BIOMET MANUFACTURING CORP.
K091608 06/03/2009 COBALT MV BONE CEMENT BIOMET MANUFACTURING CORP.
K082826 09/25/2008 VANGUARD CR STEM HOUSINGS BIOMET MANUFACTURING CORP.
K083782 12/19/2008 REGENEREX PATELLA COMPONENTS BIOMET MANUFACTURING CORP.
K110362 02/08/2011 VANGUARD ASYMMETRICAL PATELLAR COMPONENT BIOMET MANUFACTURING CORP.
K102580 09/08/2010 VANGUARD REMOVABLE MOLDED POLY TIBIA BIOMET MANUFACTURING CORP.
K060131 01/18/2006 OSS-BODIES PROXIMAL TIBIAL SLEEVE BIOMET MANUFACTURING CORP.
K060525 02/27/2006 VANGUARD REMOVABLE MOLDED POLY TIBIA BIOMET MANUFACTURING CORP.
K122160 07/20/2012 VANGUARD XP KNEE SYSTEM BIOMET MANUFACTURING CORP.
K041466 06/02/2004 TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC) BIOMET MANUFACTURING CORP.
K142658 09/18/2014 Biomet Headless Compression and Twist-off Screws BIOMET MANUFACTURING CORP.
K143188 11/05/2014 3.Omm Biomet Cannulated Screw System BIOMET MANUFACTURING CORP.
K163651 12/23/2016 ExpressBraid Graft Manipulation Biomet Manufacturing Corp.


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