CoreLink TIGER® Occipital Cervical Thoracic System. Catalog #35945-40

Vendor/Manufacturer: CoreLink

Product/Product Line: TIGER® Occipital Cervical Thoracic System

Vendor/Manufacturer Catalog #: 35945-40

Global Unique Device (GUD) Primary Device Identifier Number: M7253594540

Global Unique Device (GUD) Device Description:

3500 SERIES SCREW - LONG SHANK - 4.5MM X 40MM

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: 888.3050

FDA Regulation Description Classification Name:

Spinal interlaminal fixation orthosis

FDA Classification Product Code: MNH, MNI, KWP

FDA Classification Product Code Device Name:

MNH: Orthosis, spondylolisthesis spinal fixation

MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

FDA Premarket Submission: K132504

The CoreLink TIGER® Occipital Cervical Thoracic System is

SUBSTANTIALLY EQUIVALENT to the following products:

1. Pioneer Surgical Streamline OCT System

2. DePuy Spine Mountaineer OCT Spinal System

3. Synthes Synapse OCT System

For more information, please visit us at Infonomics.com