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 |
| 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 |
| K233150 | Narang Medical LTD. | NET BRAND Osteosynthesis Nailing System | 02/20/2024 |
| K032634 | NOVIACE CORPORATION | NORMED COMPRESSION BONE SCREW SYSTEM | 10/06/2003 |
| K014189 | ORTHOPEDIC DESIGNS, INC. | ODI TALON INTRAMEDULLARY HIP NAIL | 03/21/2002 |
| K241804 | Smith & Nephew Inc. | TRIGEN INTERTAN 10S Nail System | 08/22/2024 |
| 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 |
| K240061 | Smith & Nephew, Inc. | TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System | 09/20/2024 |
| 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 |
| K243608 | Smith & Nephew, Inc. | TRIGEN Stable Lock Nut & Washer | 06/12/2025 |
| 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 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
