SCREW 7975520 SOVEREIGN FA 5.5 X 20MM

SCREW 7975520 SOVEREIGN FA 5.5 X 20MM
SOVEREIGN™ Spinal System - 7975520

A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

No Data Available

• Outer Diameter: 5.5 Millimeter
• Length: 20.0 Millimeter

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Moist Heat or Steam Sterilization

Code: OVD

Device Name: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Device Class: 2

Physical State: Hollow cylinder or rectangular box made of metal or polymer with integrated fixation.

Definition: Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Acts as a disc spacer and holds bone graft; also includes some form of integrated fixation to maintain stability by direct purchase into the bony vertebral endplates.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Intervertebral disc space

Regulation Number: 888.3080

Third Party Flag: N

Medical Specialty: OR

Device Id: 00613994736611

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