FDA 510(k) Applications Submitted by DALENE HUFZIGER BINKLEY
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K130541 |
03/01/2013 |
SYMMETRY KERRISON DISPOSABLE TIP RONGEURS |
SYMMETRY SURGICAL |
K130669 |
03/12/2013 |
SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS |
OLSEN MEDICAL |
K070695 |
03/13/2007 |
ZIMMER PATELLOFEMORAL JOINT PROSTHESIS |
ZIMMER, INC. |
K041549 |
06/09/2004 |
ZIMMER TRABECULAR METAL HUMERAL STEM |
ZIMMER, INC. |
K181611 |
06/19/2018 |
Comprehensive Reverse Shoulder System |
Biomet Manufacturing Corp |
K071856 |
07/05/2007 |
ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S) 7848 SERIES( MODULAR NECKS), 7713 SERIES |
ZIMMER, INC. |
K042337 |
08/30/2004 |
ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING |
ZIMMER, INC. |
K133035 |
09/27/2013 |
NORMED PELLEGRIN CALCANEUS STOP SCREW |
NORMED MEDIZIN-TECHNIK GMBH |
K990032 |
01/06/1999 |
MODULAR PROTUSIO CUP |
BIOMET, INC. |
K991708 |
05/19/1999 |
ZIRCONIA 22.22MM CERAMIC MODULAR HEADS |
BIOMET, INC. |
K991987 |
06/14/1999 |
COLOR BUFFED ANSWER CEMENTED FEMORAL |
BIOMET, INC. |
K992903 |
08/30/1999 |
COLOR BUFFED CEMENTED FEMORAL |
BIOMET, INC. |
K984209 |
11/24/1998 |
STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PED |
BIOMET, INC. |
K991428 |
04/26/1999 |
ASCENT KNEE SYSTEM |
BIOMET, INC. |
K010027 |
01/03/2001 |
MAXIM KNEE SYSTEM |
BIOMET, INC. |
K020045 |
01/07/2002 |
3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM |
BIOMET ORTHOPEDICS, INC. |
K020264 |
01/25/2002 |
REPICCI II UNICONDYLAR KNEE SYSTEM |
BIOMET ORTHOPEDICS, INC. |
K030265 |
01/27/2003 |
CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00 |
ZIMMER, INC. |
K000538 |
02/17/2000 |
MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL |
BIOMET, INC. |
K060704 |
03/16/2006 |
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, SIZES 8MM AND 10MM |
ZIMMER, INC. |
K020963 |
03/25/2002 |
TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM |
BIOMET ORTHOPEDICS, INC. |
K011219 |
04/20/2001 |
ASCENT KNEE SYSTEM |
BIOMET, INC. |
K011237 |
04/23/2001 |
LACTOSORB PLATES, MESHES, AND PANELS/SHEETS |
BIOMET, INC. |
K041100 |
04/27/2004 |
NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS |
ZIMMER, INC. |
K041109 |
04/28/2004 |
ZIMMER ANATOMIC II HIP PROSTHESIS |
ZIMMER, INC. |
K021403 |
05/02/2002 |
HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED FEMORAL STEM |
BIOMET ORTHOPEDICS, INC. |
K021559 |
05/13/2002 |
ASCENT ALL-POLY PS TIBIAL BEARINGS |
BIOMET, INC. |
K011531 |
05/17/2001 |
CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER |
BIOMET, INC. |
K021661 |
05/20/2002 |
RINGLOC CONSTRAINED LINERS |
BIOMET ORTHOPEDICS, INC. |
K021728 |
05/24/2002 |
RINGLOC CONSTRAINED LINERS II |
BIOMET, INC. |
K051491 |
06/06/2005 |
TRABECULAR METAL PRIMARY HIP PROSTHESIS |
ZIMMER, INC. |
K071723 |
06/25/2007 |
ZIMMER POROLOCK MIS STEM |
ZIMMER GMBH |
K012019 |
06/28/2001 |
COLOR BUFFED (CB) DDH FEMORAL STEM |
BIOMET, INC. |
K022463 |
07/26/2002 |
HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLARED PROXIMAL POROUS FEMORAL STEMS |
BIOMET ORTHOPEDICS, INC. |
K022586 |
08/05/2002 |
ANTERIOR STABILIZED TIBIAL BEARINGS |
BIOMET ORTHOPEDICS, INC. |
K012798 |
08/21/2001 |
INTEX SCREW |
BIOMET, INC. |
K002678 |
08/28/2000 |
ASCENT KNEE SYSTEM |
BIOMET, INC. |
K023063 |
09/16/2002 |
COMPREHENSIVE HUMERAL FRACTURE SYSTEM |
BIOMET ORTHOPEDICS, INC. |
K023085 |
09/17/2002 |
RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM |
BIOMET ORTHOPEDICS, INC. |
K052906 |
10/14/2005 |
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM |
ZIMMER, INC. |
K063251 |
10/27/2006 |
ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY |
ZIMMER, INC. |
K003428 |
11/03/2000 |
ISS OFFSET HEADS |
BIOMET, INC. |
K003429 |
11/03/2000 |
MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL |
BIOMET, INC. |
K053274 |
11/23/2005 |
ANATOMICAL SHOULDER INVERSE/REVERSE |
ZIMMER GMBH |
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