Vendor/Manufacturer: Stryker
Product/Product Line: YUKON® OCT Spinal System
Vendor/Manufacturer Catalog #: 7601-63545
Global Unique Device (GUD) Primary Device Identifier Number:Â
10888857352001
Global Unique Device (GUD) Device Description:Â
Contoured Rod, Size Ø3.5x45 mm
Category 1: Spine
Category 2: Posterior Cervical Systems
Category 3:Â Rod
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:Â
Orthopedic Devices - Prosthetic Devices
FDA Regulation Number:Â 888.3075
FDA Regulation Description Classification Name:Â
Posterior cervical screw system
FDA Classification Product Code(s):Â KWP, NKG
FDA Classification Product Code Device Name(s):Â
KWP: Appliance, Fixation, Spinal Interlaminal
NKG: Orthosis, cervical pedicle screw spinal fixation
FDA Premarket Submissions: K193129
The Stryker YUKON® OCT Spinal System is
SUBSTANTIALLY EQUIVALENT to the following product(s):Â
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