NuVasive® CoRoent® Small Interlock System. Catalog #5485545

Vendor/Manufacturer: NuVasive®

Product/Product Line: CoRoent® Small Interlock System

Vendor/Manufacturer Catalog #: 5485545

Global Unique Device (GUD) Primary Device Identifier Number: 00887517250605

Global Unique Device (GUD) Device Description:

CoRoent® XLF Screw, 5.5 x 45mm Variable

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Spinal bone screw, non-bioabsorbable

Global Medical Device Nomenclature (GMDN) Definition:

A small, threaded rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a stabilization device (e.g., rod, plate) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

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