SPINEMASK (TM) TRACKER

SPINEMASK (TM) TRACKER
SPINEMASK - 6002-390-000

Device Description

A device placed on the surface of a patient's body during a surgical procedure to create identifying marks that can be seen on radiographic film or digital images for the localization and delineation of areas of interest (e.g., a tumour or lesion), or attached to navigated instruments used to assist in computer-assisted surgery. It is made from materials compatible with the imaging system in which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, nuclear medicine], or as reflective markers detected by the cameras/computer software of an image guided surgery/patient positioning system (PPS). This is a single-use device.

Environmental Conditions

Handling Environment Atmospheric Pressure - KiloPascal

106.00
70.00

Handling Environment Humidity - Percent (%) Relative Humidity

75.00
30.00

Handling Environment Temperature - Degrees Celsius

35.00
10.00

Special Storage Condition, Specify

50-106KPA

Special Storage Condition, Specify

Transport 10-90 Percent

Special Storage Condition, Specify

-20 Degrees Celsius to 70 Degrees Celsius

Storage Environment Atmospheric Pressure - KiloPascal

106.00
50.00

Storage Environment Humidity - Percent (%) Relative Humidity

85.00
30.00

Storage Environment Temperature - Degrees Celsius

35.00
4.00

Device Sizes

Height: 25.0 Millimeter

Width: 255.0 Millimeter

Length: 377.0 Millimeter

Height: 25.0 Millimeter
Width: 255.0 Millimeter
Length: 377.0 Millimeter

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

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 Identifiers

Device Id: 37613252731437

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

Device Id: 07613252731436

Device Type: Unit of Use

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