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

    SPINAL PEDICLE SCREW, FIXATION, APPLIANCE

    K Number: K952298 · Decision Dec 13, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    326
    Registration Numbers
    326
    Same Product Code
    308
    Applicant Total
    10
    Review Days
    211

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    Basic Information

    Device Name
    SPINAL PEDICLE SCREW, FIXATION, APPLIANCE
    K Number
    K952298
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    J.B.S., S.A.
    Date Received
    May 16, 1995
    Decision Date
    December 13, 1995
    Product Code
    MNH
    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
    MNH Orthosis, Spondylolisthesis Spinal Fixation

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    Other Clearances by J.B.S., S.A.

    K Number Device Name
    K962757 J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP
    K955864 J.B. S. C1-C2 CLAMP
    K953881 SPINE SYSTEM SACRAL PLATE
    K953599 CLAMP ASSEMBLY
    K942432 J.B.S. CERVICAL SPINE SYSTEM
    K940666 JBS SMOOTH FIXATION PIN
    K940669 J.B.S. B.A.C. PIN
    K940673 J.B.S. SELF-TAPPING THREADED PIN
    K935113 J.B.S. IMPLANTABLE SPINAL FIXATION DEVICE