Vendor/Manufacturer: Medtronic
Product/Product Line: Medtronic CRESCENT® Spinal System
Vendor/Manufacturer Catalog #: 7968812
Global Unique Device (GUD) Primary Device Identifier Number: 00613994517715
Global Unique Device (GUD) Device Description:
ASSEMBLY 7968812 M 37 X 27 12MM 8 DEG CP
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Bone-screw internal spinal fixation system, sterile
Global Medical Device Nomenclature (GMDN) Definition:
An assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.
FDA Regulation Medical Specialty:
Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3080
FDA Regulation Description Classification Name:
Intervertebral Body Fusion Device
FDA Classification Product Code: MAX
FDA Classification Product Code Device Name:
Intervertebral fusion device with bone graft, lumbar
The Medtronic CRESCENT® Spinal System is
SUBSTANTIALLY EQUIVALENT to the following product(s):
For more information, please visit us at Infonomics.com
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