Vendor/Manufacturer: DePuy Synthes
Product/Product Line: DELTA XTEND™ Reverse Shoulder System
Vendor/Manufacturer Catalog #: 130714100
Global Unique Device (GUD) Primary Device Identifier Number: 10603295027232
Global Unique Device (GUD) Device Description:
DELTA Xtend Monobloc Hum Cemented Epiphysis Sz1 /Dia14 STD
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Total reverse 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 joint particularly in patients with chronic, longstanding rotator cuff muscle tears, arthritis, and/or humeral fractures unsuccessfully treated by previous surgery. The device reverses normal anatomy so that the head portion of the joint is attached to the scapula and the socket portion is attached to the humerus. It typically includes a humeral stem and glenosphere (head) with body and cup components. The device may include screws for implantation and may be implanted 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): HSD, KWS
FDA Classification Product Code Device Name(s):
HSD: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
KWS: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
The DePuy DELTA XTEND™ Reverse Shoulder System is SUBSTANTIALLY EQUIVALENT to the following product(s):
For more information, please visit us at Infonomics.com
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