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

    FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)

    K Number: K003212 · Decision Dec 28, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    52
    Applicant Total
    9
    Review Days
    76

    Basic Information

    Device Name
    FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
    K Number
    K003212
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD.
    Date Received
    October 13, 2000
    Decision Date
    December 28, 2000
    Product Code
    JDS
    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
    JDS Nail, Fixation, Bone

    Similar 510(k) Clearances

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

    TRIGEN Stable Lock Nut & Washer

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRIGEN INTERTAN 10S Nail System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NET BRAND Osteosynthesis Nailing System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRIGEN META-NAIL Nail System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm

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

    Other Clearances by DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD.

    K Number Device Name
    K032588 MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM)
    K031401 FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS)
    K023437 FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM (FIXION PF NAILING SYSTEM), FIXION INTRAMEDULLARY NAIL
    K021324 FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM)
    K012967 MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEM
    K003215 MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
    K002783 FIXION INTERLOCKING NAIL (FIXION IL NAIL)
    K990717 FIXION INTRAMEDULLARY NAILING SYSTEM