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

    FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET

    K Number: K133930 · Decision Mar 27, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    8
    Review Days
    94

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    Basic Information

    Device Name
    FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET
    K Number
    K133930
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Flower Orthopedics Corporation
    Date Received
    December 23, 2013
    Decision Date
    March 27, 2014
    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 Flower Orthopedics Corporation

    K Number Device Name
    K192949 Flower Suture Anchor Set
    K170687 Flower Bone Screw Set
    K142306 Flower Upper Extremity Plating Set
    K133102 FLOWER ANKLE PLATING SET
    K132248 FLOWER BONE SCREW SET
    K131657 FLOWER SMALL AND MEDIUM IMPLANT SET
    K123562 FLOWER SMALL AND MEDIUM BONE IMPLANTS