FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K021782 |
AAP IMPLANTATE AG |
BNF |
08/26/2002 |
K192003 |
Auxein Medical Private Limited |
Auxein Nailing System |
06/10/2020 |
K011504 |
BAUMER S.A. |
BAUMER LOCKING NAIL |
08/14/2001 |
K002325 |
BIOLOGICALLY ORIENTED PROSTHESES |
WUJIN #3 TIBIAL NAIL |
10/30/2000 |
K193533 |
Biomet Inc. |
WIN Flexible Nail System |
02/20/2020 |
K000764 |
BIOMET, INC. |
PEDIATRIC FIXATION RODS |
04/06/2000 |
K141737 |
CONVENTUS ORTHOPAEDICS, INC. |
CONVENTUS PHS SYSTEM |
04/08/2015 |
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 |
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 |
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 |
K230761 |
Smith & Nephew Inc. |
TRIGEN META-NAIL Nail System |
06/14/2023 |
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 |
K201336 |
Synthes (USA) Products, LLC |
DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm |
09/03/2020 |