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

    TORQUEDRIVER WRENCH

    K Number: K870053 · Decision Mar 11, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    5
    Applicant Total
    9
    Review Days
    63

    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
    TORQUEDRIVER WRENCH
    K Number
    K870053
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Jerome Medical
    Date Received
    January 7, 1987
    Decision Date
    March 11, 1987
    Product Code
    HXC
    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
    HXC Wrench

    Similar 510(k) Clearances

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

    Intellitorq

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    ADJUSTABLE WRENCHES

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    COMBINATION WRENCHES

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    SPINAL WRENCH

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    WRENCH

    FDA 510(k)
    FDA Class 1 ·Orthopedic
    View all

    Other Clearances by Jerome Medical

    K Number Device Name
    K051918 RESOLVE OPEN BACK HALO RINGS
    K930021 J TONGS
    K930153 SYSTEM III HALO RING
    K882877 JMS CERVICAL TRACTION DEVICE/HALO DEVICE
    K864969 JMS HALO APPLICATION TRAY
    K844490 TRACTION ACCESSORIES
    K822780 CERVICAL BRACE
    K821582 WARM'N FORM SPORTS SUPPORTS