BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SIGMA® High Performance Partial Knee System

    Reg #: 3027388160 · FEI: 3027388160 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Chicago Field Inventory Location (FIL)
    Registration Number
    3027388160
    FEI Number
    3027388160
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    555 Busse Road
    City
    Elk Grove Village
    State
    IL
    ZIP
    60007
    Country
    US

    Regulatory Submissions

    510(k) Number
    K193549

    Owner / Operator

    Firm Name
    DePuy Synthes, Inc.
    Operator Number
    1818910
    Address
    700 Orthopaedic Drive
    City
    Warsaw
    State
    IN
    Postal Code
    46582
    Country
    US

    Products

    Device Name Product Code
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY

    Proprietary Names

    SIGMA® High Performance Partial Knee System

    Establishment Types

    Repack or Relabel Medical Device