Vendor/Manufacturer: Medacta International SA
Product/Product Line: AMIStem-C Femoral Stem
Vendor/Manufacturer Catalog #: 01.18.158
Global Unique Device (GUD) Primary Device Identifier Number: 07630030804335
Global Unique Device (GUD) Device Description:
AMIStem C Cemented Stem Standard Size 8
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Uncoated hip femur prosthesis, one-piece
Global Medical Device Nomenclature (GMDN) Definition:
A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is one-piece and is not coated with materials intended to improve fixation and stability. 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: 888.3360
FDA Regulation Description Classification Name:
Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis
FDA Classification Product Code(s): LZO, JDI
FDA Classification Product Code Device Name(s):
LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
The Medacta AMIStem-C Femoral Stem is
SUBSTANTIALLY EQUIVALENT to the following product(s):
For more information, please visit us at Infonomics.com
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