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

    LUBINUS SP II HIP SYSTEM

    K Number: K953653 · Decision Nov 6, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    58
    Applicant Total
    26
    Review Days
    95

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    LUBINUS SP II HIP SYSTEM
    K Number
    K953653
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3360
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Turnkey Intergration USA, Inc.
    Date Received
    August 3, 1995
    Decision Date
    November 6, 1995
    Product Code
    JDG
    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
    JDG Prosthesis, Hip, Femoral Component, Cemented, Metal

    Similar 510(k) Clearances

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

    Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Distal Centralizers

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    THE TAPER-FIT TOTAL HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM

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

    Other Clearances by Turnkey Intergration USA, Inc.

    K Number Device Name
    K991405 OMNI-FIX, HUMERAL NAIL
    K990523 B2C, ESPACE REVISION CUP SYSTEM
    K990307 OMNI-FIX, NAIL SYSTEM
    K972411 LINK CEMENT PLUG
    K970284 ARTOS, DIPLOS SYSTEM
    K970084 LINK CERCLAGE WIRE SYSTEM
    K943986 LINK ENDO MODEL REVISION CUP
    K951355 LINK SADDLE PROTHESIS
    K950397 SYSTEM 22 VALVE
    K940297 UNIVERSAL WRIST
    Search all 26 clearances from Turnkey Intergration USA, Inc. →