Vendor/Manufacturer: DJO Surgical (Enovis)
Product/Product Line: AltiVate Reverse® Shoulder System
Vendor/Manufacturer Catalog #: 530-16-048
Global Unique Device (GUD) Primary Device Identifier Number: 00190446334934
Global Unique Device (GUD) Device Description:
ALTIVATE REVERSE, HUMERAL STEM, STANDARD SHELL, SZ 16X48mm
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 Codes: HSD, KWS
FDA Classification Product Code Device Names:
HSD: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
KWS: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
FDA Premarket Submission: K190290
The DJO Surgical (Enovis) AltiVate Reverse® Shoulder System Humeral Stem, 48mm is SUBSTANTIALLY EQUIVALENT to the following products:
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