Cemented Humeral Stem


Product Overview

Cemented Humeral Stem
REUNION - 5567-C-3016


Device Description

A sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes glenoid and humeral (head and stem) components typically with parts made of metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.


Environmental Conditions

No Data Available


Device Sizes

  • Diameter: 16.0 Millimeter
  • Length: 101.0 Millimeter
    • Diameter: 16.0 Millimeter
    • Length: 101.0 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: KWS

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

    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: 888.3660

    Third Party Flag: N

    Medical Specialty: OR


    Device Identifiers

    Device Id: 07613327424881

    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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