BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OviTex PRS (LTR)

    Reg #: 3010513348 · FEI: 3010513348 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    TELA BIO, INC.
    Registration Number
    3010513348
    FEI Number
    3010513348
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1 GREAT VALLEY PKWY STE 24
    City
    Malvern
    State
    PA
    ZIP
    19355
    Country
    US

    Regulatory Submissions

    510(k) Number
    K214070

    Owner / Operator

    Firm Name
    TELA Bio
    Operator Number
    10048385
    Address
    1 Great Valley Parkway, Suite 24
    City
    Malvern
    State
    PA
    Postal Code
    19355
    Country
    US

    Products

    Device Name Product Code
    Mesh, Surgical FTM
    Mesh, Surgical, Polymeric FTL

    Proprietary Names

    OviTex PRS (LTR)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility