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Vendor/Manufacturer: Zimmer Biomet
Product/Product Line: COMPREHENSIVE® Reverse Shoulder System
Vendor/Manufacturer Catalog #: 115394
Global Unique Device (GUD) Primary Device Identifier Number: 00880304677067
Global Unique Device (GUD) Device Description:
6.5 mm Central Screw 3.5 Hex, 20mm length
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Shoulder prosthesis screw
Global Medical Device Nomenclature (GMDN) Definition:
A sterile screw or set of screws intended for implantable shoulder prosthesis assembly and/or fixation.
FDA Regulation Medical Specialty:
Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3670
FDA Regulation Description Classification Name:
Shoulder joint metal/polymer/metal non-constrained or semi-constrained porous-coated uncemented prosthesis
FDA Classification Product Code(s): KWS, PAO, PHX
FDA Classification Product Code Device Name(s):
KWS: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
PAO: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
PHX: Shoulder Prosthesis, Reverse Configuration
The Zimmer Biomet COMPREHENSIVE® Reverse Shoulder System is SUBSTANTIALLY EQUIVALENT to the following product(s):
For more information, please visit us at Infonomics.com
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