Vendor/Manufacturer: Medtronic Sofamor Danek
Product/Product Line: CD HORIZON® SOLERA® Spinal System
Vendor/Manufacturer Catalog #: 779170005
Global Unique Device (GUD) Primary Device Identifier Number: 00613994739438
Global Unique Device (GUD) Device Description:
SET SCREW 779170005 TI STD 1/4-32
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: Lumbar Pedicle Screw Systems
Category 3: Set Screw
FDA Regulation Medical Specialty:
Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3070
FDA Regulation Description Classification Name:
Thoracolumbosacral Pedicle Screw System
FDA Classification Product Code: NKB
FDA Classification Product Code Device Name:
Thoracolumbosacral Pedicle Screw System
FDA Premarket Submission: K101074
SUBSTANTIALLY EQUIVALENT to the following products:
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