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

    OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR

    K Number: K123885 · Decision Jun 3, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    5
    Applicant Total
    29
    Review Days
    167

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    Basic Information

    Device Name
    OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR
    K Number
    K123885
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osteomed LP
    Date Received
    December 18, 2012
    Decision Date
    June 3, 2013
    Product Code
    PBJ
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PBJ Cranial Distraction System

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