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

    PRACTIFIX EXTERNAL FIXATION SYSTEM

    K Number: K960014 · Decision Mar 18, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    249
    Registration Numbers
    249
    Same Product Code
    403
    Applicant Total
    8
    Review Days
    76

    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
    PRACTIFIX EXTERNAL FIXATION SYSTEM
    K Number
    K960014
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orthopaedic Innovations, Inc.
    Date Received
    January 2, 1996
    Decision Date
    March 18, 1996
    Product Code
    KTT
    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
    KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

    Similar 510(k) Clearances

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

    MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DYNEX® External Fixation Systems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    QuikFix External Fixator: Knee-Spanning Pack

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Excelsior System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Hoffmann LRF System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Monkey Rings External Ring Fixation System

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

    Other Clearances by Orthopaedic Innovations, Inc.

    K Number Device Name
    K020145 ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM
    K983881 COBRA EXTERNAL FIXATOR
    K962646 PRIME MODULAR ENDO HEAD
    K955620 PRIME CEMENTED CALCAR FEMORAL STEMS
    K955751 PRIME FEMORAL CEMENT PLUG
    K953033 PRIME CEMENTED SMALL FEMORAL STEM
    K940328 PRIME CEMENTED HIP SYSTEM