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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