Vendor/Manufacturer: Medtronic Sofamor Danek
Product/Product Line: INFINITY™ Occipitocervical Upper Thoracic System
Vendor/Manufacturer Catalog #: 3600315
Global Unique Device (GUD) Primary Device Identifier Number:
00643169541962
Global Unique Device (GUD) Device Description:
SET SCREW 3600315 STANDARD
Category 1: Spine
Category 2: Posterior Cervical Systems
Category 3: Set Screw
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Bone-screw internal spinal fixation system, non-sterile
Global Medical Device Nomenclature (GMDN) Definition:
An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.
FDA Regulation Medical Specialty:
Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3075
FDA Regulation Description Classification Name:
Posterior cervical screw system
FDA Classification Product Code(s): KWP, NKG
FDA Classification Product Code Device Name(s):
KWP: Appliance, Fixation, Spinal Interlaminal
NKG: Orthosis, cervical pedicle screw spinal fixation
FDA Premarket Submission: K163375
The Medtronic INFINITY™ Occipitocervical Upper Thoracic System is
SUBSTANTIALLY EQUIVALENT to the following product(s):
For more information, please visit us at Infonomics.com