Vendor/Manufacturer: Stryker
Product/Product Line: Modular Dual Mobility Hip System
Vendor/Manufacturer Catalog #: 626-00-48G
Global Unique Device (GUD) Primary Device Identifier Number: 04546540666031
Global Unique Device (GUD) Device Description:
Liner- Cementless
Global Medical Device Nomenclature (GMDN) Preferred Term Name: Acetabular shell Global Medical Device Nomenclature (GMDN) Definition: An implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.
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, MEH FDA Classification Product Code Device Name(s): 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
FDA Premarket Submission(s): K103233 The Stryker Modular Dual Mobility Hip System is
SUBSTANTIALLY EQUIVALENT to the following product(s): 1. Restoration® ADM System
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