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

    THREADED FIXATION PIN

    K Number: K982931 · Decision Oct 21, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    93
    Applicant Total
    8
    Review Days
    62

    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
    THREADED FIXATION PIN
    K Number
    K982931
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sgarlato Laboratories, Inc.
    Date Received
    August 20, 1998
    Decision Date
    October 21, 1998
    Product Code
    JDW
    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
    JDW Pin, Fixation, Threaded

    Similar 510(k) Clearances

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

    XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Meduloc Intramedullary Fracture Fixation (IFF) System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    XT3 System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MAVERICK Mini External Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MAVERICK External Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Steinmann Pins and Kirschner Wires

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

    Other Clearances by Sgarlato Laboratories, Inc.

    K Number Device Name
    K043204 SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP
    K990101 PAIN CONTROL INFUSION PUMP
    K926262 FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE
    K926237 O'BRIEN GONIOMETER
    K922292 LUNDEEN SUBTALAR PEG IMPLANT
    K905795 SGARLATO FLEXIBLE HINGE TOE IMPLANT
    K884739 SGARLATO LESSER TOE IMPLANT