SCREW 9000245 SI TI CANN 12X45

SCREW 9000245 SI TI CANN 12X45
RIALTO™ SI FUSION SYSTEM - 9000245

A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

No Data Available

• 12mm x 45mm

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Moist Heat or Steam Sterilization

Code: OUR

Device Name: Sacroiliac Joint Fixation

Device Class: 2

Physical State: may be used with bone graft, should not be used with bone cement

Definition: sacroiliac joint fusion

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: bridges both sides of the joint, preventing motion

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: sacroiliac joint

Regulation Number: 888.3040

Third Party Flag: N

Medical Specialty: OR

Device Id: 00643169273900

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