Vendor/Manufacturer: OrthoFix
Product/Product Line: FIREBIRD® Deformity Correction System
Vendor/Manufacturer Catalog #: 51-6320
Global Unique Device (GUD) Primary Device Identifier Number: 18257200015474
Global Unique Device (GUD) Device Description:
Mono-Axial Lateral Offset, 20mm
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:
(Orthofix Completes Acquisition of Blackstone Medical on September 25, 2006)
For more information, please visit us at Infonomics.com
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