BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    A.C. SPLINT

    K Number: K823810 · Decision Jan 14, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    326
    Registration Numbers
    326
    Same Product Code
    20
    Applicant Total
    56
    Review Days
    28

    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
    A.C. SPLINT
    K Number
    K823810
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3640
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Danek Medical, Inc.
    Date Received
    December 17, 1982
    Decision Date
    January 14, 1983
    Product Code
    ILI
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ILI Sling, Arm

    Similar 510(k) Clearances

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

    MATRX, PYRAMID TRIANGLE BANDAGE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ARM SLINGS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    SATO FAMILY FIRST AID KIT

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    VARIOUS ARM SLING

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    UNIVERSAL SLING, SLING & SWATHE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    UNIVERSAL SLING, SLING & SWATHE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine
    View all

    Other Clearances by Danek Medical, Inc.

    K Number Device Name
    K994122 BONE GRAFT WASHER, MODEL 9090114 - 9090118
    K993810 CD HORIZON SPINAL SYSTEM
    K993855 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
    K991528 MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR
    K990603 MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM
    K982875 MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
    K984522 MODIFICATION OF TSRH SPINAL SYSTEM
    K982154 MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM
    K970599 TOWNLEY PEDICLE SCREW PLATING SYSTEM
    K943827 SPINE FIXATION
    Search all 56 clearances from Danek Medical, Inc. →