BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SL-PLUS LATERALIZED STEM

    K Number: K021178 · Decision May 14, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    231
    Registration Numbers
    231
    Same Product Code
    560
    Applicant Total
    38
    Review Days
    29

    Basic Information

    Device Name
    SL-PLUS LATERALIZED STEM
    K Number
    K021178
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    PLUS ORTHOPEDICS
    Date Received
    April 15, 2002
    Decision Date
    May 14, 2002
    Product Code
    JDI
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JDI), ordered by most recent decision date.

    Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Stryker Orthopaedics Hip Systems Labeling Update

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Global Modular Replacement System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    C-Stem AMT LE Prosthesis

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    Other Clearances by PLUS ORTHOPEDICS

    K Number Device Name
    K032126 PROMOS SHOULDER
    K033763 MODIFICATION TO SLIM GLIDING NAIL SYSTEM
    K032709 MODULAR PLUS HIP STEM
    K032548 IP-XS COMPRESSION NAIL SYSTEM
    K032215 VKS/TC-PLUS REVISION KNEE
    K032052 UC-PLUS SOLUTION UNICONDYLAR KNEE
    K031165 PLUS ORTHOPEDICS CEMENTED HIP STEM
    K030971 MODIFICATION TO MODULAR PLUS REVISION STEM
    K024134 UNI HIP STEM
    K023667 RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE
    Search all 38 clearances from PLUS ORTHOPEDICS →