DRIVER 7426004 RIALTO T27 THREADED
RIALTO™ SI FUSION SYSTEM - 7426004
Device Description
A hand-held manual surgical instrument designed to impart force to an orthopaedic implantable device that is inserted to fix or fasten together bones. The device is frequently used to insert devices such as screws, nails, plates, or wires that are used to fix fractured or damaged bones and/or to attach orthopaedic prostheses to the bones. It is typically made of high-grade stainless steel or titanium (Ti). This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- Moist Heat or Steam Sterilization
Product Codes
Code: HWE
Device Name: Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
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: N
Target Area: N/A
Regulation Number: 878.4820
Third Party Flag: N
Medical Specialty: SU
Code: OLO
Device Name: Orthopedic Stereotaxic Instrument
Device Class: 2
Physical State: Device consists of Camera, computer, various shaped tracking arrays, computer interface for commmunication between user and device.
Definition: Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
Submission Type ID: 1
Review Panel: OR
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: User loads Computer software pre-Op to plan surgery procedure, then registers the patient anatomy during surgery to allow software to track patient anatomy, implants, and surgical tools in real time/space.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Orthopedic joints and spinal procedures where tracking of instrumentation is desired.
Regulation Number: 882.4560
Third Party Flag: N
Medical Specialty: NE
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 Identifiers
Device Id: 00643169572584
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
