Vendor/Manufacturer: Depuy Synthes
Product/Product Line: EXPEDIUM Set Screw
Vendor/Manufacturer Catalog #: 1797-02-000
Global Unique Device (GUD) Primary Device Identifier Number: 10705034064307
Global Unique Device (GUD) Device Description:
EXPEDIUM SPINE SYSTEM SINGLE INNER SET SCREW 5.5
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Bone-screw internal spinal fixation system, non-sterile
Category 1: Spine
Category 2: Lumbar Pedicle Screw Systems
Category 3: Set Screw
Category 4: Two Level
Quantity of "Each"es needed in each System/Set: 6
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:
Thoracolumbosacral Pedicle Screw System
FDA Premarket Submissions: K200245
SUBSTANTIALLY EQUIVALENT to the following products:
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