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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