Vendor/Manufacturer: Arthrex
Product/Product Line: ECLIPSE™ Total Shoulder Arthroplasty System
Vendor/Manufacturer Catalog #: AR-9339-16
Global Unique Device (GUD) Primary Device Identifier Number: 00888867059962
Global Unique Device (GUD) Device Description:
ARTHREX ECLIPSE HUMERAL HEAD, 39/16
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Total shoulder prosthesis
Global Medical Device Nomenclature (GMDN) Definition:
A sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes glenoid and humeral (head and stem) components typically with parts made of metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.
FDA Regulation Medical Specialty:
Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3660
FDA Regulation Description Classification Name:
Shoulder joint metal/polymer semi-constrained cemented prosthesis
FDA Classification Product Code(s): QHQ
FDA Classification Product Code Device Name(s):
Total shoulder arthroplasty system
FDA Premarket Submission: K183194 The Arthrex ECLIPSE™ Total Shoulder Arthroplasty System is SUBSTANTIALLY EQUIVALENT to the following product(s): 1. Simpliciti Shoulder System
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