Zimmer Biomet BIOLOX® delta Option Ceramic Femoral Head System. Catalog #650-1064

Vendor/Manufacturer: Zimmer Biomet

Product/Product Line: BIOLOX® delta Option Ceramic Femoral Head System

Vendor/Manufacturer Catalog #: 650-1064

Global Unique Device (GUD) Primary Device Identifier Number: 00887868248658

Global Unique Device (GUD) Device Description:

BIOLOX® delta Option Type I Insert, Size -6mm

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

FDA Premarket Submission(s): K112115 , K082996

The Zimmer Biomet BIOLOX® delta Option Ceramic Femoral Head System is SUBSTANTIALLY EQUIVALENT to the following product(s):

1. Smith & Nephew BIOLOX® delta Ceramic Femoral Heads

2. Medacta MectaCer BIOLOX® forte Femoral Heads

3. BIOLOX® delta Ceramic Heads

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