Vendor/Manufacturer: Altus Spine
Product/Product Line: VALENCIA MIS Pedicle Screw System
Vendor/Manufacturer Catalog #: 915-1911
Global Unique Device (GUD) Primary Device Identifier Number:
B41791519111
Global Unique Device (GUD) Device Description:
T25 Locking Cap
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: 888.3060
FDA Regulation Description Classification Name:
Spinal intervertebral body fixation orthosis
FDA Classification Product Code(s): KWP, KWQ, MNH, MNI, NKB
FDA Classification Product Code Device Name(s):
KWP: Appliance, Fixation, Spinal Interlaminal
KWQ: Appliance, Fixation, Spinal Intervertebral Body
MNH: Orthosis, Spondylolisthesis Spinal Fixation
MNI: Orthosis, Spinal Pedicle Fixation
NKB: Thoracolumbosacral Pedicle Screw System
FDA Premarket Submission: K151648 The Altus Spine VALENCIA MIS Pedicle Screw System is SUBSTANTIALLY EQUIVALENT to the following product(s): 1. DePuy Viper 2 System
For more information, please visit us at Infonomics.com
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