BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Q-Fix

    Reg #: 3006524618 · FEI: 3010813691 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ArthroCare Corporation
    Registration Number
    3006524618
    FEI Number
    3010813691
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7000 W William Cannon Dr
    City
    Austin
    State
    TX
    ZIP
    78735
    Country
    US

    Regulatory Submissions

    510(k) Number
    K133727

    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
    Fastener, Fixation, Nondegradable, Soft Tissue MBI

    Proprietary Names

    Q-Fix 1.8MM Q-FIX ALL-SUTURE ANCHOR WITH ONE MINITAPE SUTURE (BLUE) 1.8MM Q-FIX ALL-SUTURE ANCHOR WITH ONE MINITAPE SUTURE (COBRAID WHITE) 2.8MM Q-FIX ALL-SUTURE ANCHOR WITH TWO MINITAPE SUTURES (BLUE, COBRAID WHITE)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility