BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    Arthrex Tenodesis Button

    Reg #: 3015806723 · FEI: 3015806723 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    I-MEDICAL ASIA COMPANY LIMITED
    Registration Number
    3015806723
    FEI Number
    3015806723
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unit 18, 4/F, Block Bm Proficient Industrial Centre, 6 Wan Kwun Road
    City
    Kowloon Bay
    Country
    HK

    Regulatory Submissions

    510(k) Number
    K190288

    Owner / Operator

    Firm Name
    I-Medical Asia Company Limited
    Operator Number
    10085603
    Address
    Unit 18, 4/F, Block Bm Proficient Industrial Centre, 6 Wan Kwun Road
    City
    Kowloon Bay
    State
    HK-NOTA
    Postal Code
    HKG
    Country
    HK

    US Agent

    Business Name
    Arthrex Inc
    Contact Name
    Barry Dietz
    Address
    1370 Creekside Blvd
    City
    Naples
    State
    FL
    ZIP
    34108
    Country
    US
    Email
    [email protected]
    Phone
    800 9337001

    Products

    Device Name Product Code
    Fastener, Fixation, Nondegradable, Soft Tissue MBI

    Proprietary Names

    Arthrex Tenodesis Button

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device