BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TRI-POINT BULLET

    Reg #: 1219602 · FEI: 1219602 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SMITH & NEPHEW INC.
    Registration Number
    1219602
    FEI Number
    1219602
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ENDOSCOPY, 120 FORBES BLVD. SUITE 150 / 130 FORBES BLVD.
    City
    MANSFIELD
    State
    MA
    ZIP
    02048
    Country
    US

    Regulatory Submissions

    510(k) Number
    K832277

    Owner / Operator

    Firm Name
    Smith & Nephew, Inc.
    Operator Number
    1020279
    Address
    2875 Railroad Street
    City
    Pittsburgh
    State
    PA
    Postal Code
    15222
    Country
    US
    Correspondent
    Lisa Ewing

    Products

    Device Name Product Code
    Arthroscope HRX

    Proprietary Names

    TRI-POINT BULLET STOP DRILL PCL 11MM MULTI-TRAC PCL System; Multi-Trac PCL Drill Guide System AIMER REAR ENTRY-LEFT AIMER REAR ENTRY RIGHT-ACL REAR ENTRY INTRODUCER

    Establishment Types

    Manufacture Medical Device