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

    J.B. S. C1-C2 CLAMP

    K Number: K955864 · Decision Mar 15, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    321
    Same Product Code
    429
    Applicant Total
    10
    Review Days
    79

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    Basic Information

    Device Name
    J.B. S. C1-C2 CLAMP
    K Number
    K955864
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    J.B.S., S.A.
    Date Received
    December 27, 1995
    Decision Date
    March 15, 1996
    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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    K940666 JBS SMOOTH FIXATION PIN
    K940669 J.B.S. B.A.C. PIN
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