Vendor/Manufacturer: Stryker (K2M)
Product/Product Line: OZARK Cervical Plate System
Vendor/Manufacturer Catalog #: AA01-42F38V
Global Unique Device (GUD) Primary Device Identifier Number: 10888857401570
Global Unique Device (GUD) Device Description:
Plate, 2 Level Size 38 mm
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.
Category 1: Spine
Category 2: Cervical Plate & Screw Systems
Category 3: Plate
Category 4: Two Level
FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3060
FDA Regulation Description Classification Name:
Spinal intervertebral body fixation orthosis
FDA Classification Product Code: KWQ
FDA Classification Product Code Device Name:
Appliance, Fixation, Spinal Intervertebral Body
FDA Premarket Submission: K172104
The Stryker (K2M) OZARK Cervical Plate System is
SUBSTANTIALLY EQUIVALENT to the following products:
For more information, please visit us at Infonomics.com
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