BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    RECON system - MPJ-Plates

    K Number: K152142 · Decision Sep 16, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    9
    Review Days
    44

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    Basic Information

    Device Name
    RECON system - MPJ-Plates
    K Number
    K152142
    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
    August 3, 2015
    Decision Date
    September 16, 2015
    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
    K151407 RECON system
    K133035 NORMED PELLEGRIN CALCANEUS STOP SCREW
    K123347 NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0
    K931539 NORMED TITANIUM MINIPLATE SYSTEM