SCREW 55850011511 5.5VOYAGER MAS10.5X110

SCREW 55850011511 5.5VOYAGER MAS10.5X110
CD HORIZON® SOLERA® VOYAGER™ Spinal System - 55850011511

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

• Outer Diameter: 10.5 Millimeter

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Moist Heat or Steam Sterilization

Code: NKB

Device Name: Thoracolumbosacral Pedicle Screw System

Device Class: 2

Physical State: N/A

Definition: Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

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: 888.3070

Third Party Flag: N

Medical Specialty: OR

Code: KWQ

Device Name: Appliance, Fixation, Spinal Intervertebral Body

Device Class: 2

Physical State: N/A

Definition: N/A

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: 888.3060

Third Party Flag: N

Medical Specialty: OR

Code: KWP

Device Name: Appliance, Fixation, Spinal Interlaminal

Device Class: 2

Physical State: N/A

Definition: N/A

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

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

Device Id: 00643169768710

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