Vendor/Manufacturer: Stryker
Product/Product Line: ANATO® Femoral Hip System
Vendor/Manufacturer Catalog #: 4845-7-103
Global Unique Device (GUD) Primary Device Identifier Number: 07613252631064
Global Unique Device (GUD) Device Description:
ANTEVERTED 130 Degree Neck Angle V40 Hip Stem, Size 3 Right Anteverted
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Coated hip femur prosthesis, modular
Global Medical Device Nomenclature (GMDN) Definition:
A sterile implantable principal component of a total hip prosthesis (femoral component) 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 coated with a material (e.g., porous materials, hydroxyapatite) 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 may be performed with or without bone cement.
FDA Regulation Medical Specialty:
Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: TBD
FDA Regulation Description Classification Name:
TBD
FDA Classification Product Code(s): JDI, KWL, KWZ, LPH, LWJ, LZO, MAY, MBL, MEH,
FDA Classification Product Code Device Name(s):
JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented
KWL: Prosthesis, hip, hemi-, femoral, metal
KWZ: Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
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
MBL: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
MEH: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
FDA Premarket Submission(s): TBD
The Stryker ANATO® Femoral Hip System is
SUBSTANTIALLY EQUIVALENT to the following product(s):
1. TBD
For more information, please visit us at Infonomics.com
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