BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ENDOBUTTON CL 40MM

    Reg #: 3003604053 · FEI: 3003604053 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    20
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SMITH & NEPHEW INC.
    Registration Number
    3003604053
    FEI Number
    3003604053
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ENDOSCOPY, 150 Minuteman Rd
    City
    ANDOVER
    State
    MA
    ZIP
    01810
    Country
    US

    Regulatory Submissions

    510(k) Number
    K980155

    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
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT

    Proprietary Names

    ENDOBUTTON CL 40MM ENDOBUTTON CL/BTB/Ultra ENDOBUTTON CL FIXATION BUTTON WITH 20 MM CONTINUOUS LOOP SUTURE ENDOBUTTON CL FIXATION BUTTON WITH 30 MM CONTINUOUS LOOP SUTURE ENDOBUTTON CL ULTRA 15MM ENDOBUTTON CL ULTRA 40MM ENDOBUTTON CL 35MM ENDOBUTTON CL 45MM ENDOBUTTON CL ULTRA 25MM ENDOBUTTON CL ULTRA 30MM ENDOBUTTON CL FIXATION BUTTON WITH 25 MM CONTINUOUS LOOP SUTURE ENDOBUTTON CL ULTRA 45MM 15 MM ENDOBUTTON CL BTB ENDOBUTTON CL ULTRA 35MM ENDOBUTTON CL ULTRA 20MM ENDOBUTTON CL ULTRA 10MM ENDOBUTTON CL ULTRA 50MM ENDOBUTTON CL ULTRA 60MM ENDOBUTTON CL 50MM ENDOBUTTON CL ULTRA 55MM

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility