BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent for Some Indications 🇩🇪 Germany

    BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM

    K Number: K894184 · Decision Apr 25, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    313

    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
    BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM
    K Number
    K894184
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Biedermann Motech GmbH
    Date Received
    June 16, 1989
    Decision Date
    April 25, 1990
    Product Code
    JDN
    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
    JDN Implant, Fixation Device, Spinal

    Similar 510(k) Clearances

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

    CANNULATED FEMORAL NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NEW C-D SYSTEM FOR SPINAL SURGERY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TOTAL SPINAL CORRECTION

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

    Other Clearances by Biedermann Motech GmbH

    K Number Device Name
    K900138 MOTECH TITANIUM SURGICAL MESH