Cannulated Femoral Nail
by Synthes (Usa) 510(k)
Active
510(k) K954856
Overview
The Cannulated Femoral Nail is an implant classified as a fixation device for orthopedic use, intended for intramedullary fixation of the femur. It provides a cannulated design to allow guidewire placement and secure stabilization of femoral fractures.
The device was cleared by the FDA through a traditional 510(k) submission (K954856) and is classified as a Class II implant (product code JDN). It is marketed by Synthes (Usa) in Paoli, Pennsylvania, and is supplied as a sterile, single‑use orthopedic implant in accordance with the applicable FDA special controls.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK954856 | Date8 Mar 1996 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JDN
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3060
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent