Vendor/Manufacturer: CoreLink
Product/Product Line: TIGER® Occipital Cervical Thoracic System
Vendor/Manufacturer Catalog #: 35150-12
Global Unique Device (GUD) Primary Device Identifier Number: M7253515012
Global Unique Device (GUD) Device Description:
OCCIPITAL PLATE SCREW - 5.0MM X 12MM
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Bone-screw internal spinal fixation system, non-sterile
Global Medical Device Nomenclature (GMDN) Definition:
An assembly of non-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. Non-sterile disposable devices associated with implantation may be included.
FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3050
FDA Regulation Description Classification Name:
Spinal interlaminal fixation orthosis
FDA Classification Product Code: MNH, MNI, KWP
FDA Classification Product Code Device Name:
MNH: Orthosis, spondylolisthesis spinal fixation
MNI: ORTHOSIS, SPINAL PEDICLE FIXATION
KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
FDA Premarket Submission: K132504
The CoreLink TIGER® Occipital Cervical Thoracic System is
SUBSTANTIALLY EQUIVALENT to the following products:
For more information, please visit us at Infonomics.com
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