BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS

    Reg #: 2249615 · FEI: 3001049282 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    SCT, INC.
    Registration Number
    2249615
    FEI Number
    3001049282
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    509 Commerce St
    City
    FRANKLIN LAKES
    State
    NJ
    ZIP
    07417
    Country
    US

    Regulatory Submissions

    510(k) Number
    K113038

    Owner / Operator

    Firm Name
    SCT, INC.
    Operator Number
    9040558
    Address
    509 COMMERCE ST., --
    City
    Franklin Lakes
    State
    NJ
    Postal Code
    07417
    Country
    US
    Correspondent
    DANIEL - TORTORA

    Products

    Device Name Product Code
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer NPJ
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX

    Proprietary Names

    SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)