Vendor/Manufacturer: Zimmer Biomet
Product/Product Line: BIOLOX® delta Option Ceramic Femoral Head System
Vendor/Manufacturer Catalog #: 650-1059
Global Unique Device (GUD) Primary Device Identifier Number: 00880304510562
Global Unique Device (GUD) Device Description:
BIOLOX® delta Option Ceramic Head, Size 44mm
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Ceramic femoral head prosthesis
Global Medical Device Nomenclature (GMDN) Definition:
An implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of ceramic (e.g., alumina, zirconia). It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA) or with a bipolar component as part of a partial hip replacement. The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.
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): JDI, LPH, LWJ, LZO, MAY
FDA Classification Product Code Device Name(s):
JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented
LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
LWJ: Prosthesis, hip, semi-constrained, metal/polymer, uncemented
LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
MAY: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
The Zimmer Biomet BIOLOX® delta Option Ceramic Femoral Head System is SUBSTANTIALLY EQUIVALENT to the following product(s):
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