Vendor/Manufacturer: Medacta International SA
Product/Product Line: MPACT® Acetabular System
Vendor/Manufacturer Catalog #: 01.32.2237HCAT
Global Unique Device (GUD) Primary Device Identifier Number: 07630030811203
Global Unique Device (GUD) Device Description:
Mpact Acetabular System, Hooded PE HC Liner Ø 22 / B
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Non-constrained polyethylene acetabular liner
Global Medical Device Nomenclature (GMDN) Definition:
A sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.
FDA Regulation Medical Specialty:
Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3358
FDA Regulation Description Classification Name:
Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
FDA Classification Product Code(s): LPH, LZO
FDA Classification Product Code Device Name(s):
LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
FDA Premarket Submission(s): K103721
The Medacta MPACT® Acetabular System is SUBSTANTIALLY EQUIVALENT to the following product(s):
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