BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)

    K Number: K030972 · Decision May 30, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    106
    Applicant Total
    16
    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
    FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)
    K Number
    K030972
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3360
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Disc-O-Tech Medical Technologies, Ltd.
    Date Received
    March 28, 2003
    Decision Date
    May 30, 2003
    Product Code
    KWL
    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
    KWL Prosthesis, Hip, Hemi-, Femoral, Metal

    Similar 510(k) Clearances

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

    Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OsteoRemedies Hip Spacer System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    InterSpace GV Hip Spacer

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COPAL® exchange G hip spacer; COPAL® G+V

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UHR Bipolar Implants, Restoration GAP II Implants

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

    Other Clearances by Disc-O-Tech Medical Technologies, Ltd.

    K Number Device Name
    K071375 MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE)
    K071679 METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS
    K063067 CONFIDENCE FENESTRATED INTRODUCER NEEDLE
    K062424 CONFIDENCE EX HIGH VISCOSITY BONE CEMENT
    K060300 CONFIDENCE HIGH VISCOSITY BONE CEMENT
    K040612 SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
    K040939 SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
    K032730 FIXION HIP SYSTEM
    K034037 SKY BONE EXPANDER SYSTEM
    K032358 B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM)
    Search all 16 clearances from Disc-O-Tech Medical Technologies, Ltd. →