Vendor/Manufacturer: NuVasive
Product/Product Line: PRECEPT™ Spinal System
Vendor/Manufacturer Catalog #: 8804530A
Global Unique Device (GUD) Primary Device Identifier Number: 00887517449078
Global Unique Device (GUD) Device Description:
PRECEPT Screw, 4.5 x 30mm Polyaxial
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: 888.3070
FDA Regulation Description Classification Name:
Thoracolumbosacral pedicle screw system
FDA Classification Product Code: KWQ, KWP, MNI, NKB, MNH
FDA Classification Product Code Device Name:
KWQ: Appliance, Fixation, Spinal Intervertebral Body
KWP: Appliance, Fixation, Spinal Interlaminal
MNI: Orthosis, Spinal Pedicle Fixation
NKB: Orthosis, spinal pedicle fixation, for degenerative disc disease
MNH: Orthosis, spondylolisthesis spinal fixation
The NuVasive® PRECEPT™ Spinal System is
SUBSTANTIALLY EQUIVALENT to the following products:
For more information, please visit us at Infonomics.com
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