Vendor/Manufacturer: DePuy Synthes
Product/Product Line: CORAIL® Total Hip System
Vendor/Manufacturer Catalog #: L971308
Global Unique Device (GUD) Primary Device Identifier Number: 10603295455424
Global Unique Device (GUD) Device Description:
CORAIL HIP SYSTEM CEMENTLESS FEMORAL STEM HA COATED 12/14 AMT 135 DEGREES SHORT NECK COLLAR SIZE 8
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Coated femoral stem prosthesis, modular
Global Medical Device Nomenclature (GMDN) Definition:
A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is composed of two or more separate segments designed to be joined, typically made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.
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: MEH, KWY, KWL, LZO
FDA Classification Product Code Device Name:
MEH: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
KWY: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
KWL: Prosthesis, hip, hemi-, femoral, metal
LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
The DePuy Synthes CORAIL® Total Hip System is
SUBSTANTIALLY EQUIVALENT to the following products:
1. DePuy Summit
For more information, please visit us at Infonomics.com
Comments