FDA 510(k) Applications Submitted by CHERYL HASTINGS
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K030122 |
01/14/2003 |
DEPUY SUMMIT BASIC PRESS-FIT HIP STEM |
DEPUY ORTHOPAEDICS, INC. |
K960172 |
01/16/1996 |
DEPUY POROCOAT HPS II HIP PROSTHESIS W/ARTICUL-EZE TAPER |
DEPUY, INC. |
K000172 |
01/20/2000 |
DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
K960385 |
01/26/1996 |
STERILE KIRSCHNER WIRES AND STEINMANN PINS |
DEPUY, INC. |
K980440 |
02/04/1998 |
DEPUY ORTHOTECH PHANTOM SOF-THREAD SOFT TISSUE INTERFERENCE SCREW |
DEPUY, INC. |
K960704 |
02/09/1996 |
DEPUY M. KUROSAKA ADVANGE MANGNUM REV. INTERFERENCE SCREWS |
DEPUY, INC. |
K110459 |
02/17/2011 |
SUREFIRE INFUSION CATHETER SYSTEM |
SUREFIRE MEDICAL, INC |
K110598 |
03/02/2011 |
SMR REVERSE SHOULDER SYSTEM |
LIMACORPORATE S.P.A. |
K130642 |
03/11/2013 |
SMR 3-PEGS GLENOIDS |
LIMACORPORATE S.P.A. |
K100858 |
03/26/2010 |
LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES, |
LIMA-LTO S.P.A. |
K110847 |
03/28/2011 |
SMR SHOULDER SYSTEM - CTA HUMERAL HEADS |
LIMACORPORATE S.P.A. |
K160895 |
03/31/2016 |
Initia Total Hip System & BIOCERAM AZUL(R) HEAD |
KYOCERA Medical Corporation |
K961239 |
04/01/1996 |
DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL |
DEPUY, INC. |
K111097 |
04/20/2011 |
HUMELOCK CEMENTED SHOULDER PROSTHESIS |
FX SOLUTIONS |
K131112 |
04/22/2013 |
LIMACORPORATE SMR CTA HUMERAL HEADS |
LIMACORPORATE S.P.A. |
K111212 |
04/29/2011 |
SMR SHOULDER SYSTEM- REVISION STEMS |
LIMACORPORATE S.P.A. |
K101263 |
05/05/2010 |
LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES, |
LIMA-LTO S.P.A. |
K961791 |
05/09/1996 |
DEPUY DISPOSABLE FILTER/HOOD |
DEPUY, INC. |
K001523 |
05/16/2000 |
ULTIMA METAL-ON-METAL ACETABULAR CUP |
DEPUY ORTHOPAEDICS, INC. |
K962007 |
05/22/1996 |
PROTRUSION CAGES |
DEPUY, INC. |
K962486 |
06/26/1996 |
DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM |
DEPUY, INC. |
K962628 |
07/05/1996 |
MOSS MIAMI SPINAL SYSTEM |
DEPUY, INC. |
K972596 |
07/11/1997 |
DEPUY DURALOC ACETABULAR CUP SYSTEM |
DEPUY, INC. |
K032151 |
07/14/2003 |
DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS |
DEPUY, INC. |
K972643 |
07/15/1997 |
DEPUY AMK 3 PEG PATELLA |
DEPUY, INC. |
K112091 |
07/21/2011 |
H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS |
LIMACORPORATE S.P.A. |
K112158 |
07/27/2011 |
MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS |
LIMACORPORATE S.P.A. |
K962923 |
07/29/1996 |
DEPUY GRADED POROSITY AML HIP (1371-03/06-500/1371-43/46-500) |
DEPUY, INC. |
K092378 |
08/05/2009 |
SPECTRANETICS VISISHEATH DILATOR SHEATH |
SPECTRANETICS CORP. |
K092396 |
08/05/2009 |
SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS |
SPECTRANETICS CORP. |
K953703 |
08/08/1995 |
DEPUY VISION SOLUTION HIP PROSTHESIS |
DEPUY, INC. |
K953694 |
08/08/1995 |
DEPUY VISION AML HIP PROTHESIS |
DEPUY, INC. |
K953915 |
08/21/1995 |
MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE) |
DEPUY, INC. |
K963309 |
08/22/1996 |
APEX HOLE ELIMINATOR PS |
DEPUY, INC. |
K963350 |
08/26/1996 |
DEPUY MOTECH PEAK FIXATION SYSTEM |
DEPUY, INC. |
K112900 |
10/03/2011 |
SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS |
LIMACORPORATE S.P.A. |
K112898 |
10/03/2011 |
DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS |
LIMACORPORATE S.P.A. |
K964024 |
10/07/1996 |
DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEM |
DEPUY, INC. |
K964114 |
10/15/1996 |
DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS |
DEPUY, INC. |
K023453 |
10/15/2002 |
DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
K113254 |
11/03/2011 |
SMR MODULAR GLENOID-METAL-BACK SMR MODULAR GLENOID-LINER SMR MODULAR GLENOID-BONE SCREWS |
LIMACORPORATE S.P.A. |
K955348 |
11/21/1995 |
TITANIUM MOSS MIAMI SPINAL SYSTEM |
DEPUY, INC. |
K964704 |
11/25/1996 |
DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM |
DEPUY, INC. |
K113523 |
11/29/2011 |
LIMACORPORATE SMR REVERSE SHOULDER SYSTEM |
LIMACORPORATE S.P.A. |
K965145 |
12/23/1996 |
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM |
DEPUY, INC. |
K955884 |
12/28/1995 |
COORDINATE REVISION KNEE SYSTEM |
DEPUY, INC. |
K994415 |
12/29/1999 |
MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS |
DEPUY ORTHOPAEDICS, INC. |
K040166 |
01/26/2004 |
DEPUY SIGMA XLK TIBIAL INSERTS |
DEPUY ORTHOPAEDICS, INC. |
K980513 |
02/10/1998 |
ARTICUL/EZE FEMORAL HEADS |
DEPUY ORTHOPAEDICS, INC. |
K021933 |
06/12/2002 |
TEMPFIX EXTERNAL FIXATION SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
K982330 |
07/02/1998 |
DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT |
DEPUY, INC. |
K002883 |
09/15/2000 |
PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS |
DEPUY ORTHOPAEDICS, INC. |
K033272 |
10/10/2003 |
DEPUY SIGMA TIBIAL INSERTS |
DEPUY ORTHOPAEDICS, INC. |
K974573 |
12/08/1997 |
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM |
DEPUY, INC. |
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