Stryker (K2M) OZARK Cervical Plate System. Catalog #8801-04526DA-G1

CataBlog
May 16, 2022
1 min read

Vendor/Manufacturer: Stryker (K2M)

Product/Product Line: OZARK Cervical Plate System

Vendor/Manufacturer Catalog #: 8801-04526DA-G1

Global Unique Device (GUD) Primary Device Identifier Number: 10888857409309

Global Unique Device (GUD) Device Description:

Self-Starting, Variable Screw, Size Ø4.5x26 mm

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Bone-screw internal spinal fixation system, sterile

Global Medical Device Nomenclature (GMDN) Definition:

An assembly of 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. Sterile disposable devices associated with implantation may be included.

Category 1: Spine

Category 2: Cervical Plate & Screw Systems

Category 3: Screw

FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3060

FDA Regulation Description Classification Name:

Spinal intervertebral body fixation orthosis

FDA Classification Product Code: KWQ

FDA Classification Product Code Device Name:

Appliance, Fixation, Spinal Intervertebral Body

FDA Premarket Submission: K172104

The Stryker (K2M) OZARK Cervical Plate System is