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

    NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0

    K Number: K123347 · Decision Aug 2, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    9
    Review Days
    275

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    Basic Information

    Device Name
    NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0
    K Number
    K123347
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Normed Medizin-Technik GmbH
    Date Received
    October 31, 2012
    Decision Date
    August 2, 2013
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

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    Other Clearances by Normed Medizin-Technik GmbH

    K Number Device Name
    K151708 RECON system - Compression Screws
    K151701 Tenodesis screw system
    K152256 RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws
    K152312 RECON system-V-TEK-IVP Plates and Screws
    K152142 RECON system - MPJ-Plates
    K151407 RECON system
    K133035 NORMED PELLEGRIN CALCANEUS STOP SCREW
    K931539 NORMED TITANIUM MINIPLATE SYSTEM