FDA 510(k) Applications Submitted by TRACY J BICKEL, RAC
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K991009 |
03/26/1999 |
RC BUTTRESS |
BIOMET, INC. |
K002423 |
08/08/2000 |
LACTOSORB PUSH SCREW |
BIOMET, INC. |
K060131 |
01/18/2006 |
OSS-BODIES PROXIMAL TIBIAL SLEEVE |
BIOMET MANUFACTURING CORP. |
K070364 |
02/07/2007 |
100KGY E-POLY MAXROM ACETABULAR LINERS |
BIOMET, INC. |
K050327 |
02/09/2005 |
E-POLY (VITAMIN E) ACETABULAR LINERS |
BIOMET, INC. |
K060525 |
02/27/2006 |
VANGUARD REMOVABLE MOLDED POLY TIBIA |
BIOMET MANUFACTURING CORP. |
K141331 |
05/21/2014 |
BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS) |
BIOMET, INC. |
K051411 |
05/31/2005 |
ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS |
BIOMET, INC. |
K051843 |
07/07/2005 |
COPELAND EAS HUMERAL RESURFACING HEADS |
BIOMET, INC. |
K122160 |
07/20/2012 |
VANGUARD XP KNEE SYSTEM |
BIOMET MANUFACTURING CORP. |
K140509 |
02/28/2014 |
BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE |
BIOMET MANUFACTURING LLC |
K061433 |
05/24/2006 |
VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE |
BIOMET MANUFACTURING, INC. |
K142814 |
09/29/2014 |
Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial |
BIOMET MANUFACTURING LLC |
K020076 |
01/09/2002 |
PATRIOT PROTRUSIO CAGE |
BIOMET ORTHOPEDICS, INC. |
K030446 |
02/11/2003 |
REPICCI LOCKED KEEL TIBIAL BEARING |
BIOMET, INC. |
K040500 |
02/26/2004 |
ARTHROTEK LACTONAIL |
ARTHROTEK, INC. |
K020962 |
03/25/2002 |
G4 SLEEVED NAIL |
BIOMET MANUFACTURING, INC. |
K020970 |
03/26/2002 |
MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS) |
BIOMET, INC. |
K011139 |
04/13/2001 |
LORENZ LACTOSORB PANELS AND FASTENERS |
BIOMET, INC. |
K021182 |
04/15/2002 |
RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR |
BIOMET, INC. |
K041046 |
04/22/2004 |
MAXIM ACCEL (VANGUARD) PS+ BEARINGS |
BIOMET, INC. |
K001376 |
05/01/2000 |
TI-MAX PROTRUSIO CAGE |
BIOMET, INC. |
K011455 |
05/11/2001 |
BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER |
BIOMET, INC. |
K011509 |
05/16/2001 |
BARRETT UNICONDYLAR TIBIAL BEARING |
BIOMET, INC. |
K011795 |
06/08/2001 |
WORLAND UNICONDYLAR TIBIAL BEARING |
BIOMET, INC. |
K001760 |
06/09/2000 |
RADIOLUCENT COLLES FRACTURE KIT |
BIOMET, INC. |
K022094 |
06/27/2002 |
PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING |
BIOMET, INC. |
K032072 |
07/03/2003 |
LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE |
ARTHROTEK, INC. |
K002106 |
07/12/2000 |
NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER |
BIOMET, INC. |
K992355 |
07/14/1999 |
LACTOSORB TRAUMA PLATING SYSTEM |
BIOMET, INC. |
K032286 |
07/24/2003 |
CALCIGEN PSI BONE GRAFT SUBSTITUTE |
BIOMET ORTHOPEDICS, INC. |
K042051 |
07/30/2004 |
ARCOMXL POLYETHYLENE LINERS |
BIOMET, INC. |
K022531 |
07/31/2002 |
2MM PEDIATRIC FLEX NAIL |
BIOMET, INC. |
K993159 |
09/21/1999 |
MAXIM KNEE SYSTEM |
BIOMET, INC. |
K023357 |
10/07/2002 |
ARCPM 1050 RESIN-HIPS |
BIOMET ORTHOPEDICS, INC. |
K003240 |
10/17/2000 |
BIOMET EXTERNAL WRIST PLATE |
BIOMET, INC. |
K003294 |
10/20/2000 |
BIOMET LATERAL TROCH PLATE |
BIOMET, INC. |
K003296 |
10/20/2000 |
BIOMET SCK KNEE SYSTEM |
BIOMET, INC. |
K023546 |
10/22/2002 |
MAXIM ACCEL KNEE SYSTEM |
BIOMET, INC. |
K013557 |
10/24/2001 |
LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW |
WALTER LORENZ SURGICAL, INC. |
K033506 |
11/05/2003 |
COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE |
BIOMET, INC. |
K013657 |
11/06/2001 |
MODIFICATION TO: BIOMET HUMERAL CABLE PLATES |
BIOMET ORTHOPEDICS, INC. |
K984390 |
12/08/1998 |
LACTOSORB PANELS AND FASTENERS |
BIOMET, INC. |
K994184 |
12/10/1999 |
PLR SPLINED REVISION STEM |
BIOMET, INC. |
K033838 |
12/10/2003 |
TITANIUM TOGGLE BUTTON(S) |
BIOMET MANUFACTURING, INC. |
K994326 |
12/22/1999 |
ASCENT KNEE SYSTEM |
BIOMET MANUFACTURING, INC. |
K041466 |
06/02/2004 |
TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC) |
BIOMET MANUFACTURING CORP. |
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