Vendor/Manufacturer: NuVasive®
Product/Product Line: CoRoent® Small Interlock System
Vendor/Manufacturer Catalog #: 6808340
Global Unique Device (GUD) Primary Device Identifier Number: 00887517365552
Global Unique Device (GUD) Device Description:
CoRoent® XLW, 8x22x40mm Lordotic
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Metallic spinal fusion cage, non-sterile
Global Medical Device Nomenclature (GMDN) Definition:
A non-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) made of metal [usually titanium (Ti)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for therapeutic spinal bone fusion to occur. Disposable devices associated with implantation may be included. This device must be sterilized prior to use.
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(s): ODP
FDA Classification Product Code Device Name(s):
Intervertebral Fusion Device With Bone Graft, Cervical
FDA Premarket Submission(s): K081611 , K192582 , K102547 The NuVasive® CoRoent® Small Interlock System is SUBSTANTIALLY EQUIVALENT to the following product(s):
1. Centinel Spine STALIF C System 2. Centinel Spine STALIF C-Ti System 3. NuVasive® Archon Anterior Cervical Plate System 4. NuVasive® CoRoent Small Interbody System 5. Surgicraft Limited STALIF™ C 6. Synthes Spine Synthes Zero-P 7. Globus Medical Coalition™ Spacer 8. SeaSpine, Inc. Zuma-C™ 9. NuVasive, Inc. CoRoent XLR Standalone System 10. Medtronic Sofamor Danek PEEK PREVAIL™ Cervical lnterbody Device For more information, please visit us at Infonomics.com
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