INST KIT 9735303 TAP AWL-TIP 4.0-4.5


Product Overview

INST KIT 9735303 TAP AWL
N/A - 9735303


Device Description

A surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a reusable device.


Environmental Conditions

No Data Available


Device Sizes

  • 4.0-4.5mm
    • 4.0-4.5mm


    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: 00643169319790

    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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