OrthoFix FIREBIRD® Deformity Correction System. Catalog #51-3325

Vendor/Manufacturer: OrthoFix

Product/Product Line: FIREBIRD® Deformity Correction System

Vendor/Manufacturer Catalog #: 51-3325

Global Unique Device (GUD) Primary Device Identifier Number: 18257200014484

Global Unique Device (GUD) Device Description:

4.0mm x 25mm Uniplanar Screw, Self-Tapping

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Bone-screw internal spinal fixation system

Global Medical Device Nomenclature (GMDN) Definition:

An assembly of 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. 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: NKB

FDA Classification Product Code Device Name:

Orthosis, spinal pedicle fixation, for degenerative disc disease

FDA Premarket Submission: K082797

(Orthofix Completes Acquisition of Blackstone Medical on September 25, 2006)

The OrthoFix FIREBIRD® Deformity Correction System is

SUBSTANTIALLY EQUIVALENT to the following products:

1. Synthes Pangea Spine System

2. Blackstone Medical, Inc. Pedicle Screw System

(Orthofix Completes Acquisition of Blackstone Medical on September 25, 2006)

For more information, please visit us at Infonomics.com