Vendor/Manufacturer: DePuy Synthes
Product/Product Line: MOUNTAINEER Screw
Vendor/Manufacturer Catalog #: 1883-18-314
Global Unique Device (GUD) Primary Device Identifier Number: 10705034157184
Global Unique Device (GUD) Device Description:
MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 3.5 x 14mm
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Bone-screw internal spinal fixation system, non-sterile
Category 1: Spine
Category 2: Cervical Pedicle Screw Systems
Category 3: 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: 888.3050
FDA Regulation Description Classification Name:
Spinal interlaminal fixation orthosis
FDA Classification Product Code: KWP
FDA Classification Product Code Device Name:
Appliance, Fixation, Spinal Interlaminal
SUBSTANTIALLY EQUIVALENT to the following products:
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