JDS — Nail, Fixation, Bone Class II
FDA product code JDS covers "Nail, Fixation, Bone", a Class II medical device regulated under 21 CFR 888.3030. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JDS
- Device Class
- Class II
- Regulation Number
- 888.3030
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243608 | smith and nephew | TRIGEN Stable Lock Nut & Washer | June 12, 2025 |
| K240061 | smith and nephew | TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System | September 20, 2024 |
| K241804 | smith and nephew | TRIGEN INTERTAN 10S Nail System | August 22, 2024 |
| K233150 | narang medical | NET BRAND Osteosynthesis Nailing System | February 20, 2024 |
| K230761 | smith and nephew | TRIGEN META-NAIL Nail System | June 14, 2023 |
| K201336 | synthes (usa) products | DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails | September 3, 2020 |
| K192003 | auxein medical private limited | Auxein Nailing System | June 10, 2020 |
| K193533 | biomet | WIN Flexible Nail System | February 20, 2020 |
| K141737 | conventus orthopaedics | CONVENTUS PHS SYSTEM | April 8, 2015 |
| K123948 | smith and nephew | CHINA NAILS AND ACCESSORIES | March 14, 2013 |
| K111667 | synthes (usa) | SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS | December 5, 2011 |
| K080706 | i.t.s. implantat-technologie-systeme | CONNEXX LOCKING TIBIA NAIL | June 9, 2008 |
| K072095 | synthes (usa) | SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS | September 27, 2007 |
| K062872 | synthes (usa) | SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM | March 13, 2007 |
| K061783 | smith and nephew | KNEE FUSION NAIL | August 10, 2006 |
| K061019 | smith and nephew | TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS | June 6, 2006 |
| K051557 | smith and nephew | TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS | June 30, 2005 |
| K050938 | smith and nephew | KNEE FUSION NAIL | May 4, 2005 |
| K040762 | synthes (usa) | SYNTHES (USA) TIBIAL NAIL SYSTEM EX | April 12, 2004 |
| K040212 | smith and nephew | TRIGEN INTERTAN | February 20, 2004 |