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

    EDWARDS ADJUSTABLE CONNECTORS

    K Number: K915672 · Decision May 26, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    330
    Registration Numbers
    330
    Same Product Code
    429
    Applicant Total
    2
    Review Days
    526

    Basic Information

    Device Name
    EDWARDS ADJUSTABLE CONNECTORS
    K Number
    K915672
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    SCIENTIFIC SPINAL LTD.
    Date Received
    December 17, 1991
    Decision Date
    May 26, 1993
    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

    Similar 510(k) Clearances

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

    LnK Posterior Cervical Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OASYS System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Sure Lok Mini Posterior Cervical/Upper Thoracic System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Reliance Posterior Cervical-Thoracic System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Streamline OCT Occipito-Cervico-Thoracic System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SOLSTICE OCT System

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

    Other Clearances by SCIENTIFIC SPINAL LTD.

    K Number Device Name
    K914269 EDWARDS ANATO HOOK/UNIV ROD/WASH/SACR SCREW/ADJ CO