Vendor/Manufacturer: Medtronic Sofamor Danek
Product/Product Line: ANATOMIC PEEK™ PTC Cervical Fusion System
Vendor/Manufacturer Catalog #: 5030564
Global Unique Device (GUD) Primary Device Identifier Number: 00643169357570
Global Unique Device (GUD) Device Description:
CAGE 5030564 ANATOMIC PTC 16 X 14 X 5MM
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Polymeric spinal fusion cage, sterile
Global Medical Device Nomenclature (GMDN) Definition:
A sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Fixation screws and disposable devices associated with implantation may be included with the device.
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: ODP
FDA Classification Product Code Device Name:
ODP: Intervertebral fusion device with bone graft, cervical
FDA Premarket Submissions: K133653
The Medtronic Sofamor Danek ANATOMIC PEEK™ PTC Cervical Fusion System is SUBSTANTIALLY EQUIVALENT to the following product(s):
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