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

    CLAMP ASSEMBLY

    K Number: K953599 · Decision Dec 19, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    321
    Same Product Code
    429
    Applicant Total
    10
    Review Days
    139

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    Basic Information

    Device Name
    CLAMP ASSEMBLY
    K Number
    K953599
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    J.B.S., S.A.
    Date Received
    August 2, 1995
    Decision Date
    December 19, 1995
    Product Code
    KWP
    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
    KWP Appliance, Fixation, Spinal Interlaminal

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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
    K952298 SPINAL PEDICLE SCREW, FIXATION, APPLIANCE
    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