BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HEALICOIL Knotless REGENESORB Suture Anchor, 5.5mm, Self-Tapping

    Reg #: 3003604053 · FEI: 3003604053 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    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
    K193558

    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, Biodegradable, Soft Tissue MAI
    Fastener, Fixation, Nondegradable, Soft Tissue MBI

    Proprietary Names

    HEALICOIL Knotless REGENESORB Suture Anchor, 5.5mm, Self-Tapping HEALICOIL Knotless REGENESORB Suture Anchor, 5.5mm HEALICOIL Knotless PK Suture Anchor, 5mm HEILICOIL Knotless Drill, 4.75mm HEALICOIL Knotless PK Suture Anchor, 5mm, Self-Tapping

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility