Vendor/Manufacturer: Zimmer Biomet
Product/Product Line: BIOLOX® delta Option Ceramic Femoral Head System
Vendor/Manufacturer Catalog #: 650-1066
Global Unique Device (GUD) Primary Device Identifier Number: 00880304520158
Global Unique Device (GUD) Device Description:
BIOLOX® delta Option Type I Insert, Size Std
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Femoral head/stem prosthesis adaptor
Global Medical Device Nomenclature (GMDN) Definition:
A sterile implantable tubular device designed to connect a femoral head prosthesis to the trunnion of a femoral stem prosthesis. It is typically intended to be used as part of a total hip arthroplasty (THA) revision to correct offset, neck length, lateralization, and anteversion/retroversion where there is a good fitting stem; it may also be used as part of a primary procedure. It is made of metal [e.g., titanium (Ti) alloy] and is available in various sizes and shapes; it is intended to be used with a dedicated femoral head prosthesis.
FDA Regulation Medical Specialty:
Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3353
FDA Regulation Description Classification Name:
Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
FDA Classification Product Code(s): LZO
FDA Classification Product Code Device Name(s):
LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
The Zimmer Biomet BIOLOX® delta Option Ceramic Femoral Head System is SUBSTANTIALLY EQUIVALENT to the following product(s):
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