Vendor/Manufacturer: DePuy Synthes
Product/Product Line: SUMMIT® Tapered Hip System
Vendor/Manufacturer Catalog #: 1570-03-090
Global Unique Device (GUD) Primary Device Identifier Number: 10603295059530
Global Unique Device (GUD) Device Description:
SUMMIT FEMORAL STEM 12/14 TAPER CEMENTED SIZE 3 STD 108mm
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Uncoated hip femur prosthesis, modular
Global Medical Device Nomenclature (GMDN) Definition:
A sterile implantable principal component of a total hip prosthesis (femoral component) typically designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with bone cement.
FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3350
FDA Regulation Description Classification Name:
Hip joint metal/polymer semi-constrained cemented prosthesis
FDA Classification Product Codes: JDI, LZO
FDA Classification Product Code Device Names:
JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented
LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
The DePuy Synthes SUMMIT® Tapered Hip System is
SUBSTANTIALLY EQUIVALENT to the following products:
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