FDA 510(k) Applications Submitted by GARY BAKER, M.S. RAC
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K140018 |
01/03/2014 |
TSP HIP FRACTURE PLATING SYSTEM |
BIOMET, INC. |
K080204 |
01/28/2008 |
VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS |
BIOMET, INC. |
K050222 |
01/31/2005 |
VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS |
BIOMET, INC. |
K050251 |
02/03/2005 |
BALANCE HIP SYSTEM |
BIOMET, INC. |
K040610 |
03/08/2004 |
VERSA-DIAL HUMERAL HEAD |
BIOMET MANUFACTURING, INC. |
K080979 |
04/07/2008 |
STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT |
BIOMET MANUFACTURING CORP. |
K101086 |
04/19/2010 |
TAPERLOC COMPLETE |
BIOMET, INC. |
K051069 |
04/26/2005 |
NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER |
ARTHROTEK, INC. |
K031334 |
04/28/2003 |
TEXAS T - PLATE |
BIOMET, INC. |
K041261 |
05/11/2004 |
FEMORAL HOOK |
ARTHROTEK, INC. |
K041274 |
05/12/2004 |
RESORBABLE INTERFERENCE SCREW |
ARTHROTEK, INC. |
K131393 |
05/15/2013 |
MAK OSS FEMORAL KNEE COMPONENTS |
BIOMET ORTHOPEDICS CORP. |
K041352 |
05/20/2004 |
COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM |
BIOMET, INC. |
K051479 |
06/03/2005 |
RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS |
BIOMET MANUFACTURING, INC. |
K031734 |
06/04/2003 |
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS |
BIOMET, INC. |
K031804 |
06/11/2003 |
COMPRESS DISTAL FEMORAL REPLACEMENT |
BIOMET, INC. |
K041988 |
07/23/2004 |
ARTHROTEK MENISCAL HYBRID DEVICE |
BIOMET, INC. |
K032396 |
08/04/2003 |
RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS |
BIOMET, INC. |
K042409 |
09/03/2004 |
MODULAR ARTHRODESIS NAIL |
BIOMET, INC. |
K042460 |
09/10/2004 |
TI - SCREW ANCHOR SP |
ARTHROTEK, INC. |
K063002 |
10/02/2006 |
ALTRA PRESS-FIT HIP SYSTEM |
BIOMET MANUFACTURING CORP. |
K112905 |
10/03/2011 |
COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM |
BIOMET ORTHOPEDICS LLC. |
K042757 |
10/04/2004 |
VANGUARD SSK KNEE SYSTEM |
BIOMET, INC. |
K093235 |
10/15/2009 |
RINGLOC + HYBRID ACETABULAR SYSTEM |
BIOMET, INC. |
K093293 |
10/21/2009 |
VANGUARD 360 REVISION KNEE SYSTEM |
BIOMET, INC. |
K113271 |
11/04/2011 |
METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS |
BIOMET MANUFACTURING, INC. |
K033519 |
11/07/2003 |
CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET |
BIOMET, INC. |
K043100 |
11/09/2004 |
BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS |
BIOMET, INC. |
K123501 |
11/13/2012 |
OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS |
BIOMET, INC. |
K113550 |
12/01/2011 |
VANGUARD COMPLETE KNEE SYSTEM |
BIOMET MANUFACTURING CORP. |
K043505 |
12/20/2004 |
DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM |
BIOMET, INC. |
K043547 |
12/23/2004 |
COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM |
BIOMET, INC. |
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. |
K102125 |
07/29/2010 |
PATIENT-SPECIFIC VANGUARD FEMORAL COMPONETS |
BIOMET, INC. |
K070015 |
01/03/2007 |
COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT |
BIOMET MANUFACTURING CORP. |
K954998 |
11/01/1995 |
LILY DARK VIEWER |
LILY IMAGING SOLUTIONS CO. |
K954999 |
11/01/1995 |
LILY MULTICANNULA GUIDE |
LILY IMAGING SOLUTIONS CO. |
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