Product Overview

BONE FILE
Legion - E0016202-1


Device Description

A hand-held, manually-operated, instrument that has various forms of fine ridged cutting surfaces along part of or all of its working end that is used for cutting and smoothing (filing) bone tissue. It is made of high-grade steel and may be a one-piece instrument with a handle at the proximal end. The distal end may be flat or profiled (e.g., flat on one side and convex on the other). This device is typically used in orthopaedics, plastic surgery and dentistry. 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
    • Moist Heat or Steam Sterilization


    Product Codes

    Code: HRY

    Device Name: Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

    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: 888.3530

    Third Party Flag: N

    Medical Specialty: OR


    Device Identifiers

    Device Id: 00885556731567

    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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