Long Univ Handle Adaptor instrument Rosa one 3.1 (spine application) Adaptor for universal handle, long"


Product Overview

Long Univ Handle Adaptor instrument Rosa one 3.1 (spine application) Adaptor for universal handle, long"
LONG UNIV HANDLE ADP - 174034-00


Device Description

An electrically-powered assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during a surgical procedure of more than one discipline [e.g., orthopaedic and ear/nose/throat (ENT)]. The system may include computerized functions to store diagnostic images used for image-guided surgery.


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
    • Moist Heat or Steam Sterilization


    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: 03760244031938

    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


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