Medacta AMIStem-C Femoral Stem. Catalog #01.18.157

Vendor/Manufacturer: Medacta International SA

Product/Product Line: AMIStem-C Femoral Stem

Vendor/Manufacturer Catalog #: 01.18.157

Global Unique Device (GUD) Primary Device Identifier Number: 07630030804328

Global Unique Device (GUD) Device Description:

AMIStem C Cemented Stem Standard Size 7

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

FDA Premarket Submission(s): K103189 , K193433

The Medacta AMIStem-C Femoral Stem is

SUBSTANTIALLY EQUIVALENT to the following product(s):

1. Medacta Quadra C Short Neck femoral stem

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