Vendor/Manufacturer: DePuy Synthes
Product/Product Line: Femoral Recon Nail System
FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3020
FDA Regulation Description Classification Name:
Intramedullary Fixation Rod
FDA Classification Product Code: HSB
FDA Classification Product Code Device Name:
Rod, Fixation, Intramedullary And Accessories
SUBSTANTIALLY EQUIVALENT to the following products:
Device Description:
The Femoral Recon Nail (FRN) System is comprised of intramedullary nailing implants designed to provide stabilization of femoral shaft and neck fractures as well as system specific insertion instruments. The Femoral Recon Nail System offers nailing implants in two different designs which enable a Piriformis Fossa (PF) and a Greater Trochanter (GT) entry point for the insertion of the nailing implant in the femur.
The implants are manufactured from Titanium alloy, are provided in a range of dimensions and in Left and Right-oriented versions.
Indications for Use:
The Femoral Recon Nail System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.
Specifically, the system is indicated for:
Subtrochanteric fractures
Ipsilateral neck/shaft fractures
Femoral shaft fractures
Impending pathologic fractures
Malunions and nonunions
Comentários