FDA 510(k) Applications for Medical Device Product Code "JDS"
(Nail, Fixation, Bone)

FDA 510(k) Number Applicant Device Name Decision Date
K021782 AAP IMPLANTATE AG BNF 08/26/2002
K943855 ACUMED, INC. BONE FIXATION NAIL 07/12/1995
K926465 APPLIED OSTEO SYSTEMS, INC. FEMORAL INTRAMEDULLARY RODS 08/25/1993
K011504 BAUMER S.A. BAUMER LOCKING NAIL 08/14/2001
K002325 BIOLOGICALLY ORIENTED PROSTHESES WUJIN #3 TIBIAL NAIL 10/30/2000
K800144 BIOMET, INC. FEMORAL CEMENT RESTRICTOR 02/19/1980
K000764 BIOMET, INC. PEDIATRIC FIXATION RODS 04/06/2000
K141737 CONVENTUS ORTHOPAEDICS, INC. CONVENTUS PHS SYSTEM 04/08/2015
K884406 DE MEDICA MFG., INC. TRACER HIP PINNING SYSTEM 11/28/1988
K800894 DEPUY, INC. DUPUY CEMENT RESTRICTOR TRIALS & INSTR. 05/02/1980
K003212 DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) 12/28/2000
K003215 DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) 12/27/2000
K800898 DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS SILASTIC BONE PLUG H.P.(CEMENT RESTRICT) 05/02/1980
K770130 HOWMEDICA CORP. B.G. FLEXIBLE NAIL SYSTEM 01/26/1977
K940736 HOWMEDICA CORP. HAIG NAIL 09/12/1994
K883882 HOWMEDICA CORP. HUMERAL LOCKING NAIL SYSTEM 01/30/1989
K924004 HOWMEDICA CORP. SEIDEL HUMERAL LOCKING NAIL -- ADDITIONAL LENGTHS 11/23/1992
K993004 HOWMEDICA OSTEONICS CORP. ALTA FULLY THREADED CROSS-LOCKING 5.0 MM SCREW 10/06/1999
K080706 I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH CONNEXX LOCKING TIBIA NAIL 06/09/2008
K991877 INNERVISION, INC. MACMED PAEDIATRIC INTRAMEDULLARY NAIL 08/06/1999
K832328 KIRSCHNER MEDICAL CORP. INTRAMEDULLARY BONE PLUG 10/20/1983
K840242 LATHAM MANUFACTURER POLY PLUG CEMENT RESTRICTOR 05/30/1984
K951302 MEDPAC SMALL FRAGMENT PLATES AND SCREWS 05/05/1995
K991037 MODULAR CUTTING SYSTEMS, INC. EUCLID REDUCTION AND GUIDANCE SYSTEM 06/23/1999
K032634 NOVIACE CORPORATION NORMED COMPRESSION BONE SCREW SYSTEM 10/06/2003
K014189 ORTHOPEDIC DESIGNS, INC. ODI TALON INTRAMEDULLARY HIP NAIL 03/21/2002
K123948 SMITH & NEPHEW, INC. CHINA NAILS AND ACCESSORIES 03/14/2013
K983942 SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP 12/04/1998
K050938 SMITH & NEPHEW, INC. KNEE FUSION NAIL 05/04/2005
K061783 SMITH & NEPHEW, INC. KNEE FUSION NAIL 08/10/2006
K981529 SMITH & NEPHEW, INC. TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW 07/09/1998
K040212 SMITH & NEPHEW, INC. TRIGEN INTERTAN 02/20/2004
K061019 SMITH & NEPHEW, INC. TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS 06/06/2006
K051557 SMITH & NEPHEW, INC. TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS 06/30/2005
K033071 SYNTHES (USA) SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM 11/05/2003
K972516 SYNTHES (USA) SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM 09/04/1997
K062872 SYNTHES (USA) SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM 03/13/2007
K072095 SYNTHES (USA) SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS 09/27/2007
K040762 SYNTHES (USA) SYNTHES (USA) TIBIAL NAIL SYSTEM EX 04/12/2004
K002729 SYNTHES (USA) SYNTHES PROXIMAL HUMERAL NAIL 10/06/2000
K992348 SYNTHES (USA) SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN) 09/23/1999
K111667 SYNTHES (USA) SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS 12/05/2011
K962047 SYNTHES (USA) TITANIUM CANNULATED TIBIAL NAIL (TI CTN) 07/24/1996
K914371 SYNTHES (USA) UNIVERSAL FEMORAL NAIL 02/18/1992
K914453 SYNTHES (USA) UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL 02/18/1992
K800142 ZIMMER, INC. FUSON BONE PLUG, RADIOPAQUE 02/19/1980


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