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

    FX-CABLELOK SYSTEM, MODIFICATION

    K Number: K915259 · Decision Feb 7, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    128
    Applicant Total
    30
    Review Days
    80

    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
    FX-CABLELOK SYSTEM, MODIFICATION
    K Number
    K915259
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3010
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biodynamic Technologies, Inc.
    Date Received
    November 19, 1991
    Decision Date
    February 7, 1992
    Product Code
    JDQ
    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
    JDQ Cerclage, Fixation

    Similar 510(k) Clearances

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

    Stitch Cerclage – Suture Tapes

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Mbrace Cable

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCORD Cable System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VariTrax Sternal CircumFixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Arthrex Radiopaque FiberTape Cerclage sutures

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

    Other Clearances by Biodynamic Technologies, Inc.

    K Number Device Name
    K990436 ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM
    K990481 ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM
    K990513 ULTIMAX CORTICAL BONE SCREWS
    K981230 ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM
    K980102 BTI HUMERAL INTRAMEDULLARY ROD SYSTEM
    K974756 BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS
    K972403 BTI CORTICAL BONE SCREWS
    K970897 BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM
    K962706 EZ-FIX CANNULATED SCREW SYSTEM
    K962987 EZ-FIX SMALL CANNULATED SCREW SYSTEM
    Search all 30 clearances from Biodynamic Technologies, Inc. →