Vendor/Manufacturer: DePuy Synthes
Product/Product Line: CORAIL® Total Hip System
Vendor/Manufacturer Catalog #: L20320
Global Unique Device (GUD) Primary Device Identifier Number: 10603295258094
Global Unique Device (GUD) Device Description:
CORAIL HIP SYSTEM CEMENTLESS FEMORAL STEM 12/14 AMT 135 DEGREES KHO SIZE 20 HA COATED HIGH OFFSET NO COLLAR
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Uncoated hip femur prosthesis, modular
Global Medical Device Nomenclature (GMDN) Definition:
A sterile implantable principal component of a total hip prosthesis (femoral component) typically designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. 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: 888.3353
FDA Regulation Description Classification Name:
Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
FDA Classification Product Codes: LZO, MEH, LWJ, KWA
FDA Classification Product Code Device Names:
LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MEH: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
LWJ: Prosthesis, hip, semi-constrained, metal/polymer, uncemented
KWA: Prosthesis, hip, semi-constrained (metal uncemented acetabular component)
The DePuy Synthes CORAIL® Total Hip System is
SUBSTANTIALLY EQUIVALENT to the following products:
1. DePuy Summit
2. DePuy Titan
For more information, please visit us at Infonomics.com
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