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

    Flower Bone Screw Set

    K Number: K170687 · Decision Jun 6, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    8
    Review Days
    91

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    Basic Information

    Device Name
    Flower Bone Screw Set
    K Number
    K170687
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Flower Orthopedics Corporation
    Date Received
    March 7, 2017
    Decision Date
    June 6, 2017
    Product Code
    HWC
    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
    HWC Screw, Fixation, Bone

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    Other Clearances by Flower Orthopedics Corporation

    K Number Device Name
    K192949 Flower Suture Anchor Set
    K142306 Flower Upper Extremity Plating Set
    K133930 FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT 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