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

    TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG

    K Number: K810193 · Decision Mar 20, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    19
    Applicant Total
    14
    Review Days
    56

    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
    TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG
    K Number
    K810193
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5960
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Ace Orthopedic Manufacturing Co.
    Date Received
    January 23, 1981
    Decision Date
    March 20, 1981
    Product Code
    HAX
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HAX Tong, Skull For Traction

    Similar 510(k) Clearances

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

    PMT HALO SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D

    FDA 510(k)
    FDA Class 2 ·Neurology

    RESOLVE OPEN BACK HALO RINGS

    FDA 510(k)
    FDA Class 2 ·Neurology

    JEROME GLASS RING

    FDA 510(k)
    FDA Class 2 ·Neurology

    SPINE WORKS COLLAR

    FDA 510(k)
    FDA Class 2 ·Neurology

    FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM

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

    Other Clearances by Ace Orthopedic Manufacturing Co.

    K Number Device Name
    K934643 ACE HUMERAL NAIL
    K934962 AIM SUPRACONDYLAR NAIL
    K936045 ACE UNILATERAL FIXATOR II
    K926047 ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW
    K920738 ACE 100 DEGREES TUBULAR PLATE
    K813554 ACE/KYLE CAPTURED HIP SCREW
    K801594 ACE FISCHER EXTERNAL FIXATION DEVICE
    K791466 ACE EXTERNAL BONE CLAMP PART #S11
    K781839 BONE CLAMP, ACE EXTERNAL
    K781840 EXTERNAL ARTICULATION
    Search all 14 clearances from Ace Orthopedic Manufacturing Co. →