Vendor/Manufacturer: DePuy Synthes
Product/Product Line: ZERO-P VA Implant
Vendor/Manufacturer Catalog #: 04.647.127S
Global Unique Device (GUD) Primary Device Identifier Number:
10705034750736
Global Unique Device (GUD) Device Description:
ZERO-P VA IMPLANT 7MM HEIGHT LORDOTIC-STERILE
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Polymeric spinal interbody fusion cage
Category 1: Spine
Category 2: Interbody Fusion with Integrated Screws - Cervical
Category 3: Implant
Category 4: Cervical
Quantity of "Each"es needed in each System/Set: 1
FDA Regulation Medical Specialty:
Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3080
FDA Regulation Description Classification Name:
Intervertebral body fusion device
FDA Classification Product Code: OVE
FDA Classification Product Code Device Name:
Intervertebral Fusion Device With Integrated Fixation, Cervical
FDA Premarket Submissions: K112068
SUBSTANTIALLY EQUIVALENT to the following products:
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