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

    LIMA CEMENT RESTRICTOR

    K Number: K911338 · Decision Jun 28, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    53
    Applicant Total
    26
    Review Days
    94

    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
    LIMA CEMENT RESTRICTOR
    K Number
    K911338
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Turnkey Intergration USA, Inc.
    Date Received
    March 26, 1991
    Decision Date
    June 28, 1991
    Product Code
    JDK
    Advisory Committee
    General, Plastic Surgery
    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
    JDK Prosthesis, Hip, Cement Restrictor

    Similar 510(k) Clearances

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

    Mectaplug PE II

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    KMI CEMENT RESTRICTOR IMPLANT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LIFE SPINE CEMENT RESTRICTOR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SPINAL USA CEMENT RESTRICTOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    INTERBODY INNOVATIONS CEMENT RESTRICTOR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    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
    K953653 LUBINUS SP II HIP SYSTEM
    K943986 LINK ENDO MODEL REVISION CUP
    K951355 LINK SADDLE PROTHESIS
    K950397 SYSTEM 22 VALVE
    Search all 26 clearances from Turnkey Intergration USA, Inc. →