FDA 510(k) Applications Submitted by HOWMEDICA OSTEONICS CORP

FDA 510(k) Number Submission Date Device Name Applicant
K123166 10/09/2012 TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P HOWMEDICA OSTEONICS CORP
K090897 04/01/2009 TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT HOWMEDICA OSTEONICS CORP
K091955 07/01/2009 STRYKER SONICPIN SYSTEM HOWMEDICA OSTEONICS CORP
K103104 10/20/2010 SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT HOWMEDICA OSTEONICS CORP
K103233 11/02/2010 MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT HOWMEDICA OSTEONICS CORP
K103835 12/30/2010 REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N HOWMEDICA OSTEONICS CORP
K123604 11/21/2012 ABG III MONOLITHIC HIP STEM HOWMEDICA OSTEONICS CORP
K081044 04/14/2008 REJUVENATE MODULAR HIP SYSTEM HOWMEDICA OSTEONICS CORP
K082892 09/30/2008 REJUVENATE MONOLITHIC HIP SYSTEM HOWMEDICA OSTEONICS CORP
K042343 08/30/2004 SCORPIO NRG KNEE SYSTEM HOWMEDICA OSTEONICS CORP
K042883 10/19/2004 SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT HOWMEDICA OSTEONICS CORP
K042993 11/01/2004 TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENT HOWMEDICA OSTEONICS CORP
K033716 11/26/2003 TRIDENT ACETABULAR SYSTEM HOWMEDICA OSTEONICS CORP
K033769 12/03/2003 EIUS UNICOMPARTMENTAL KNEE SYSTEM HOWMEDICA OSTEONICS CORP
K043374 12/08/2004 DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATITE COATING HOWMEDICA OSTEONICS CORP
K033971 12/22/2003 SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATING HOWMEDICA OSTEONICS CORP
K033972 12/22/2003 SCORPIO TOTAL KNEE SYSTEM HOWMEDICA OSTEONICS CORP
K130895 04/01/2013 REUNION RSA SHOULDER SYSTEM HOWMEDICA OSTEONICS CORP
K091161 04/21/2009 REJUVENATE MONOLITHIC SIZE 4 HIP STEM HOWMEDICA OSTEONICS CORP
K092561 08/21/2009 REJUVENATE MODULAR STEM HOWMEDICA OSTEONICS CORP
K060360 02/13/2006 HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE WITH OFFSET ADAPTERS HOWMEDICA OSTEONICS CORP
K070454 02/16/2007 OMEGA 3 SUPRACONDYLAR PLATE HOWMEDICA OSTEONICS CORP
K070963 04/05/2007 REUNION HA FRACTURE STEM HOWMEDICA OSTEONICS CORP
K061168 04/27/2006 PCA 36MM FEMORAL HEADS HOWMEDICA OSTEONICS CORP
K062037 07/19/2006 TRIATHLON LOW PROFILE TIBIAL TRAY HOWMEDICA OSTEONICS CORP
K062066 07/21/2006 OMEGA 3 SYSTEM HOWMEDICA OSTEONICS CORP
K082567 09/04/2008 STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION HOWMEDICA OSTEONICS CORP
K063445 11/15/2006 PCA CONSTRAINED ACETABULAR LINERS HOWMEDICA OSTEONICS CORP
K063550 11/24/2006 SYSTEM 12 CONSTRAINED ACETABULAR LINERS HOWMEDICA OSTEONICS CORP
K063552 11/24/2006 SERIES II CONSTRAINED ACETABULAR LINERS HOWMEDICA OSTEONICS CORP
K053349 12/02/2005 HOFFMANN II ROD TO WIRE COUPLING HOWMEDICA OSTEONICS CORP
K073527 12/17/2007 VARIAX ELBOW SYSTEM HOWMEDICA OSTEONICS CORP
K061654 06/13/2006 TRIDENT CONSTRAINED ACETABULAR INSERT HOWMEDICA OSTEONICS CORP
K050539 03/02/2005 SIZE 1 TRIATHLON POSTERIOR STABILIZED (PS) TIBIAL INSERT HOWMEDICA OSTEONICS CORP
K040964 04/14/2004 SCORPIO TOTAL KNEE SYSTEM - POSTERIOR STABILIZED TIBIAL INSERTS HOWMEDICA OSTEONICS CORP
K101072 04/19/2010 TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE HOWMEDICA OSTEONICS CORP
K121308 05/01/2012 HIP SYSTEMS HOWMEDICA OSTEONICS CORP
K051146 05/04/2005 TRIATHLON KNEE SYSTEM HOWMEDICA OSTEONICS CORP
K051363 05/25/2005 RESTORATION MODULAR SYSTEM HOWMEDICA OSTEONICS CORP
K071471 05/29/2007 CORIN ADAPTOR SLEEVE HOWMEDICA OSTEONICS CORP
K041591 06/14/2004 SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS HOWMEDICA OSTEONICS CORP
K051588 06/15/2005 BIOLOX DELTA CERAMIC FEMORAL HEADS HOWMEDICA OSTEONICS CORP
K051737 06/28/2005 MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE HOWMEDICA OSTEONICS CORP
K051738 06/28/2005 SECUR-FIT MAX AND PLUS MAX HIP STEMS HOWMEDICA OSTEONICS CORP
K051977 07/21/2005 SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS HOWMEDICA OSTEONICS CORP
K072020 07/23/2007 RESTORATION ADM SYSTEM HOWMEDICA OSTEONICS CORP
K052718 09/29/2005 V40 BIOLOX DELTA CERAMIC FEMORAL HEADS HOWMEDICA OSTEONICS CORP
K052748 09/30/2005 SYSTEM 12 X3 ACETABULAR INSERTS; SERIES II X3 ACETABULAR INSERTS HOWMEDICA OSTEONICS CORP
K081171 04/24/2008 TRITANIUM ACETABULAR SHELL SYSTEM HOWMEDICA OSTEONICS CORP
K063616 12/05/2006 TRIDENT II ACETABULAR SYSTEM HOWMEDICA OSTEONICS CORP
K040128 01/21/2004 MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS HOWMEDICA OSTEONICS CORP
K040267 02/05/2004 TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEE HOWMEDICA OSTEONICS CORP
K040749 03/23/2004 MODULAR REPLACEMENT SYSTEM CEMENTED STEMS HOWMEDICA OSTEONICS CORP
K101438 05/24/2010 T2 GREATER TROCHANTER NAIL HOWMEDICA OSTEONICS CORP
K071991 07/20/2007 MODIFICATION TO SCORPIO NRG KNEE SYSTEM HOWMEDICA OSTEONICS CORP
K041940 07/19/2004 HOWMEDICA OSTEONICS ZIRCONIA-TOUGHENED-ALUMINA (BIOLOX DELTA) CERAMIC FEMORAL HEADS HOWMEDICA OSTEONICS CORP
K070095 01/10/2007 TRIATHLON TS KNEE SYSTEM HOWMEDICA OSTEONICS CORP
K070885 03/30/2007 UNIVERSAL TAPER DELTA FEMORAL HEAD HOWMEDICA OSTEONICS CORP
K061434 05/24/2006 TRIDENT LARGE DIAMETER HIP SYSTEM HOWMEDICA OSTEONICS CORP
K051380 05/27/2005 TRIATHLON PRESS-FIT TOTAL KNEE SYSTEM HOWMEDICA OSTEONICS CORP
K061521 06/02/2006 TRIATHLON METAL BACKED PATELLA HOWMEDICA OSTEONICS CORP
K061677 06/15/2006 SOLAR PUREFIX HA SHOULDER HOWMEDICA OSTEONICS CORP
K062419 08/18/2006 TRIDENT LARGE DIAMETER ACETABULAR INSERTS HOWMEDICA OSTEONICS CORP
K053198 11/16/2005 SIMPLEX P SPEEDSET BONE CEMENT HOWMEDICA OSTEONICS CORP
K110290 02/01/2011 EXETER HIP STEM HOWMEDICA OSTEONICS CORP
K112556 09/02/2011 ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS HOWMEDICA OSTEONICS CORP
K122853 09/18/2012 NOVEL FIT AND FILL STEM HOWMEDICA OSTEONICS CORP
K050048 01/10/2005 HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS CORP
K060514 02/27/2006 STRYKER PLATING SYSTEM HOWMEDICA OSTEONICS CORP
K071082 04/17/2007 STRYKER MODULAR HIP SYSTEM HOWMEDICA OSTEONICS CORP
K051624 06/20/2005 T2 RECON NAIL SYSTEM HOWMEDICA OSTEONICS CORP
K071881 07/09/2007 TRIATHLON PKR SYSTEM HOWMEDICA OSTEONICS CORP
K051948 07/18/2005 AVON PATELLO-FEMORAL JOINT PROSTHESIS HOWMEDICA OSTEONICS CORP
K052037 07/28/2005 MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS CORP
K052917 10/17/2005 STRYKER COMPARTMENTAL KNEE SYSTEM HOWMEDICA OSTEONICS CORP
K053038 10/27/2005 HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS CORP
K053348 12/02/2005 STRYKER ORTHOPAEDICS RFID INSTRUMENTATION HOWMEDICA OSTEONICS CORP
K053472 12/14/2005 HOFFMANN II MRI EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS CORP


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact