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Medtronic Sofamor Danek CORNERSTONE PSR. Interbody Fusion Device. Cervical. Non-Bone. Cat #6278744

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Vendor/Manufacturer: Medtronic Sofamor Danek/Titan

Product/Product Line: CORNERSTONE PSR Interbody Fusion Device

Vendor/Manufacturer Catalog #: 6278744

Global Unique Device (GUD) Primary Device Identifier Number:

00721902807572

Global Unique Device (GUD) Device Description:

SPACER 6278744 CRNS PSR 7 X 14 X 14MM

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Vertebral body prosthesis

FDA Regulation Medical Specialty:

Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3060

FDA Regulation Description Classification Name:

Spinal intervertebral body fixation orthosis

FDA Classification Product Code: MQP

FDA Classification Product Code Device Name:

Spinal Vertebral Body Replacement Device


Category 1: Spine

Category 2: Interbody Fusion Devices

Category 3: Cervical

Category 4: Non-Bone


FDA Premarket Submissions: K030736 , K192502


SUBSTANTIALLY EQUIVALENT to the following product(s):

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