SELF DRILLING SCREW

SELF DRILLING SCREW
ESCALATE - 48570210

A small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; 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 typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

No Data Available

• Length: 10.0 Millimeter
• Diameter: 2.0 Millimeter

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Moist Heat or Steam Sterilization

Code: NQW

Device Name: Orthosis, Spine, Plate, Laminoplasty, Metal

Device Class: 2

Physical State: N/A

Definition: This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure.

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 888.3050

Third Party Flag: N

Medical Specialty: OR

Device Id: 07613252464174

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A