Stryker Xia® 3 Spinal System. Catalog #48238040

Vendor/Manufacturer: Stryker Spine

Product/Product Line: Xia® 3 Spinal System

Vendor/Manufacturer Catalog #: 48238040

Global Unique Device (GUD) Primary Device Identifier Number:

04546540560919

Global Unique Device (GUD) Device Description:

TI ALLOY RAD ROD

Category 1: Spine

Category 2: Lumbar Pedicle Screw Systems

Category 3: Rod

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:

Pedicle Screw Spinal System

FDA Classification Product Code(s): KWP, MNH, MNI, NKB, OSH

FDA Classification Product Code Device Name(s):

KWP: Appliance, Fixation, Spinal Interlaminal

MNH: Orthosis, spondylolisthesis spinal fixation

MNI: Orthosis, Spinal Pedicle Fixation

NKB: Orthosis, spinal pedicle fixation, for degenerative disc disease

OSH: Pedicle screw spinal system, adolescent idiopathic scoliosis