BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ACTERA (femoral stems sizes 0,1,10,11,12 and patient specific neck sizes 0-12)

    Reg #: 3004153240 · FEI: 3004153240 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ConforMIS, Inc.
    Registration Number
    3004153240
    FEI Number
    3004153240
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    600 Research Dr
    City
    Wilmington
    State
    MA
    ZIP
    01887
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231178

    Owner / Operator

    Firm Name
    restor3d, Inc.
    Operator Number
    9058483
    Address
    4001 NC-54, Suite 3160
    City
    Durham
    State
    NC
    Postal Code
    27709
    Country
    US
    Correspondent
    Brianna Prindle

    Products

    Device Name Product Code
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH

    Proprietary Names

    ACTERA (femoral stems sizes 0,1,10,11,12 and patient specific neck sizes 0-12) Femoral Trial Heads, reusable ACTERA Trial Necks ACTERA Broaches 0,1,10,11,12

    Establishment Types

    Manufacture Medical Device