Vendor/Manufacturer: Globus Medical
Product/Product Line: CREO AMP Screw
Vendor/Manufacturer Catalog #: 1067.1645
Global Unique Device (GUD) Primary Device Identifier Number: 00889095016543
Global Unique Device (GUD) Device Description:
6.5 x 45mm Screw, Modular, CREO AMP
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Trans-facet-screw internal spinal fixation system, sterile
Category 1: Spine
Category 2: Lumbar Pedicle Screw Systems
Category 3: Screw
Category 4: One Level
Quantity of "Each"es needed in each System/Set: 4
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: OSH
FDA Classification Product Code Device Name:
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
SUBSTANTIALLY EQUIVALENT to the following products:
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